WO2023004588A1 - Perioperative-period management apparatus and method based on muscle tissue oxygen monitoring, and application thereof - Google Patents
Perioperative-period management apparatus and method based on muscle tissue oxygen monitoring, and application thereof Download PDFInfo
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Definitions
- the invention belongs to the field of management medical methods, and in particular relates to a perioperative management device, method and application thereof based on muscle tissue oxygen monitoring.
- PONV postoperative nausea and vomiting
- the present invention provides a perioperative management device, comprising: an information collection module, a data processing module and a display module;
- the information collection module is used to collect sign information (the information may be a signal) of the managed object, such as muscle tissue oxygen information and/hemodynamic sign information;
- the data processing module is connected with the information collection module, which is used to receive and process the sign information of the management object, so as to convert it into sign parameters, such as muscle tissue oxygen parameters and hemodynamic parameters.
- the data processing module can also compare one or more of the physical sign parameters with reference parameters.
- said data processing module is capable of storing or can be input with reference parameters.
- the data processing module is used to analyze the relationship between the muscle tissue oxygen parameter, the hemodynamic parameter and the baseline value of each parameter or the area under the target curve.
- the analysis result of the data processing module it is determined whether to enter the management mode or enter the next parameter judgment mode.
- the display module is connected with the data processing module, and is used for displaying the visualized data output by the data processing module.
- the muscle tissue oxygen (SmtO 2 ) is selected from flank SmtO 2 and/or forearm SmtO 2 .
- said hemodynamic signs include cardiac output (CO) and blood pressure (BP).
- the determinants of cardiac output include stroke rate (SV) and heart rate (HR).
- the determinants of blood pressure include cardiac output and systemic vascular resistance (SVR).
- the information collection module includes a signal collection module, and the information collection module includes a signal collection module, and the signal collection module is used to collect the sign signal of the managed object, such as muscle tissue oxygen signal and/or blood Fluid signs.
- the information collection module or signal collection module includes a signal collector for collecting a sign signal of the subject, such as a muscle tissue oxygen signal and/or a hemodynamic sign signal.
- the signal collector includes a first signal collector, a second signal collector, a third signal collector, a fourth signal collector and/or a fifth signal collector;
- the first signal collector is used to collect flank SmtO 2
- the second signal collector is used to collect forearm SmtO 2
- the third signal collector is used to collect blood pressure signals
- the fourth signal collector is used to collect heart rate (SV)
- the fifth signal collector is used to collect heart rate (HR).
- the signal collector includes a sensor that directly collects the sign signal.
- the data processing module includes a signal processor for receiving and processing the signal collected by the sensor in the signal collector.
- the data processing module includes a muscle tissue oxygen data processing module and a hemodynamic parameter data processing module connected with the muscle tissue oxygen data processing module.
- the signal processor includes a first signal processor and a second signal processor, the first signal processor is set in the muscle tissue oxygen data processing module, and the second signal processor is set in the hemodynamic Learning parameter data processing module.
- the first signal processor is used to convert the muscle tissue oxygen signal of the managed subject into corresponding parameters
- the second signal processor is used to convert the hemodynamic parameter signal of the managed subject into corresponding parameters.
- the muscle tissue oxygen data processing module includes side abdomen SmtO 2 data processing modules and forearm SmtO 2 data processing modules; when the SmtO 2 monitoring value in at least one data processing module ⁇ 70% (lower than the target curve Area (AUC) value) or lower than its baseline value (preferably the higher of the two values) for a duration ⁇ 60s, start to enter the hemodynamic parameter data processing module; if not, then Keep monitoring.
- AUC target curve Area
- the hemodynamic parameter data processing module includes a sequentially connected cardiac output data processing module, a systemic vascular resistance data processing module, and a blood pressure data processing module.
- a sequentially connected cardiac output data processing module When the relationship between the monitoring value and the preset value of the parameter is judged as “No”, it prompts to enter the next parameter judgment mode; when it is "Yes”, it prompts to enter the management mode. "No” can be divided into two situations: reaching the preset value and not reaching the preset value, which mainly depends on the sign parameters to be judged.
- the cardiac output data processing module includes a parallel and interconnected heart rate data processing module and a beat rate data processing module.
- the beat rate data processing module includes parallel preload data processing module, afterload data processing module and contraction force data processing module, and the preload data processing module and afterload data processing module are respectively connected with the contraction force data processing module .
- the monitoring value of the cardiac output data processing module when the monitoring value of the cardiac output data processing module reaches the baseline value of the parameter, it prompts to check the beat rate data processing module. When the monitoring value of the cardiac output data processing module does not reach the baseline value of the parameter, it prompts to enter the preload data processing module or the afterload data processing module. Further, when the monitoring value of the preload data processing module or afterload data processing module does not reach the baseline value or scalar difference of the parameter, it prompts to enter the contraction force data module; when the baseline value or scalar value of the parameter is reached When the value is different, it prompts to enter the management mode.
- the management device further includes a central processing unit and/or one or more memories, the central processing unit is used as data receiving, processing and final processing and execution unit of each module, and the memory is used for Place the above modules.
- the central processing unit may be composed of one or more processors. The various modules stored in the memory are run or executed by the central processing unit to perform various functions of the device and process data.
- connection between the above modules may be a wired connection and/or a wireless connection, for example, the wireless connection may be a cloud connection.
- the display module includes a display screen providing a display interface, and the display screen may be touch-type or non-touch-type.
- the display module further includes a display controller, configured to control the display and/or update of output visual graphics, text, pictures, and the like.
- the management device further includes a communication module, configured to receive communication signals and convert them into electrical signals, and convert the electrical signals into communication signals before sending them.
- the communication module can be selected from component modules known in the art.
- the communication module can use any one of communication standards, protocols, etc., including but not limited to using wired media or wireless media for communication, such as Bluetooth, Ethernet or other wireless protocols.
- the management device can communicate with an external network or other devices through a communication module.
- the management device may further include a power supply system to provide power for each module, element or circuit in the device.
- the management device further includes a peripheral interface, which is respectively connected to the central processing unit, the signal collector, the communication module, the display controller, and the like.
- the present invention also provides a management method of physiological parameters or physiological data (such as perioperative physiological parameters or physiological data), including using the above-mentioned perioperative management device to process perioperative physiological parameters or physiological data.
- physiological parameters or physiological data such as perioperative physiological parameters or physiological data
- the present invention also provides a method for analyzing physiological parameters or physiological data (such as perioperative physiological parameters or physiological data), including using the above-mentioned perioperative management device to analyze perioperative physiological parameters or physiological data.
- physiological parameters or physiological data such as perioperative physiological parameters or physiological data
- the present invention also provides a perioperative management method, comprising the following steps:
- the subject when the baseline value is measured, the subject is awake, calm, without anxiety, lying flat, with eyes slightly closed, without fasting, about 1-2 hours after a meal, without bowel preparation, and without dehydration. No acute illness, no pain, calm breathing air;
- the intervention treatment will be started , so that the cardiac output (CO) and blood pressure (BP) of the managed subjects can be maintained in the normal range;
- the muscle SmtO 2 monitoring value still does not fall within the above range, start to check other factors, and carry out intervention management based on the influencing factors obtained from the check;
- the management method includes the following steps:
- the subject when the baseline value is measured, the subject is awake, calm, without anxiety, lying flat, eyes slightly closed, not fasting, about 1-2 hours after a meal, no bowel preparation, and no dehydration , no acute illness, no pain, calm breathing air;
- the muscle tissue oxygen includes flank SmtO 2 , and forearm SmtO 2 or lower limb SmtO 2 ;
- the hemodynamic signs include CO and BP; the CO includes stroke volume (SV), heart rate (HR) and systemic vascular resistance (SVR);
- intervention treatment methods can be adopted to increase myocardial preload, enhance myocardial contractility and/or reduce myocardial afterload; if not, examine the HR monitoring value and its baseline value Relationship;
- step (1) it is necessary to ensure the accuracy and reliability of the baseline value, and the above parameters can be measured repeatedly if necessary.
- the managed subject in step (1), should also be in a sedated state and be able to breathe indoor air.
- the managed subjects show anxiety, they are lightly sedated; for example, propofol (for example, the dosage is 10-20 mg) or midazolam (for example, the dosage is 1-4 mg) can be administered to them.
- the management object is a general surgery patient, that is, a relatively young and healthy patient undergoing a medium-low risk surgery.
- This management usually has no major perioperative complications and, instead, the immediate priority is to facilitate postoperative recovery.
- the management objects can be extended to other patients, including high-risk surgical operations, high-risk surgical patients, and the like.
- the present invention has no limitation on the subjects to be managed, the surgery and the degree of risk.
- the management object is a patient with three or more PONV (postoperative nausea and vomiting) risk factors, for example, is a female, non-smoking and is expected to receive opioids Analgesic patients.
- the physical condition of the managed subject belongs to the I-III physical condition classified by the American Society of Anesthesiologists: normal health classification (I), mild systemic disease (II) and severe systemic disease (III).
- the operation performed on the managed object is a selective laparoscopic operation including hysterectomy.
- the management objects do not include patients who are planned to undergo vaginal or open hysterectomy, urgent or urgent surgery or involving bowel resection, nor do they have major systemic comorbidities or have received hysterectomy within 3 months before surgery Patients undergoing chemotherapy or radiation therapy.
- the baseline measurement value can be obtained by connecting the management object with the above-mentioned management device.
- the connection modes between the device and the management object are all non-intrusive connections.
- a finger cuff of the device is worn on the subject's left hand to monitor systemic hemodynamics, while an arm cuff for non-invasive blood pressure measurement is typically used on the right upper arm for daily management.
- the infusion intervention is an intravenous bolus injection of Lactated Ringer’s solution (LR, preferably 250 ml in one bolus) to the management object within 2-3 minutes.
- step (4) when considering reducing myocardial afterload, it is necessary to check whether the SVR monitoring value is greater than its baseline value.
- the management object can be considered for pain relief, avoiding hypoxia, avoiding hypercapnia, and/or intervention to expand arteries; if not, consider increasing myocardial contractility.
- pain relief can be achieved by intravenous injection of sufentanil, and the dose is based on clinical judgment; arterial expansion can be achieved by infusion of nicardipine.
- the way to increase myocardial contractility can be infusion of dobutamine, increase of calcium ion (when calcium ion concentration is low) and/or bolus injection of ephedrine (when blood pressure is low).
- the intervention method for restoring HR may be to apply a small dose of atropine, for example, bolus injection of 0.1-0.2 mg intravenously; it can be repeated when necessary. If blood pressure is low at the same time, ephedrine (5-10 mg) can be used as a substitute.
- HR range is 50-100bpm. However, fine-tuning of HR within this range is allowed. If HR is outside this range, a senior anesthesiologist should be consulted for advice.
- the intervention method for reducing SVR may be infusion of nicardipine (for example, the infusion amount is 1-5 mg/h), so as to dilate arterioles.
- the infusion amount is 1-5 mg/h
- cardiac output can be increased, and on the other hand, tissue perfusion can be improved by reducing blood flow resistance.
- step (7) when the BP monitoring value is lower than 80% of its baseline value and the CO is higher than its baseline value, phenylephrine infusion or ephedrine can be considered
- the other factors include low arterial blood oxygen content, high muscle metabolic rate, high intra-abdominal pressure and/or muscle compression.
- hypovolemia plasma levels
- hypothermia should be used to keep the body temperature in the range of 36-37°C; when muscles are in motion, muscle twitching should be checked and muscle relaxants should be used in a clinically appropriate manner.
- the intra-abdominal pressure when the intra-abdominal pressure is high, it can be inflated to make the abdominal pressure ⁇ 10cm H 2 O.
- the management method of the present invention it is preferably performed using the management device.
- the present invention also provides the application of the above-mentioned device or method in a system for inhibiting and/or treating perioperative complications.
- the present invention also provides the use of the above-mentioned device in processing, managing or analyzing perioperative physiological parameters or physiological data, such as perioperative physiological parameters or physiological data.
- the present invention also provides the application of the above-mentioned device in a system for processing, managing or analyzing perioperative physiological parameters or physiological data (eg, perioperative physiological parameters or physiological data).
- perioperative physiological parameters or physiological data eg, perioperative physiological parameters or physiological data
- the present invention also provides the application of the above-mentioned device or method in the prevention and/or treatment of perioperative complications.
- the complications may be complications arising from the treatment of diseases related to muscle tissue oxygenation and hemodynamics (such as cerebral hemorrhage, massive bleeding, hysterectomy, etc.), such as PONV.
- the device or method is preferably for use in the inhibition and/or treatment of PONV during peri-laparoscopic hysterectomy, eg for reducing the incidence of 24-hour PONV after laparoscopic hysterectomy.
- the present invention also provides the application of the above device or method in the diagnosis of perioperative hypotension.
- the present invention also provides the application of the above device or method in promoting postoperative recovery.
- the perioperative period includes the management periods before, during and after surgery.
- the present invention monitors and manages the muscle tissue oxygen and hemodynamic sign data of the perioperative management object, and compares the monitoring value of the muscle tissue oxygen and hemodynamic sign parameters of the managed object during the operation with the preoperative baseline value. It can reasonably intervene in various situations that arise during the operation, so as to reduce the incidence of postoperative complications of the managed objects and reduce the hospitalization period of the managed objects.
- hypoperfusion of the gastrointestinal tract may be one of the potential causes of PONV, but the existing technology cannot directly monitor the perfusion of the gastrointestinal tissue in patients, nor can it meet the adequacy of the metabolic needs of the gastrointestinal tissue. While the superficial location of skeletal muscle allows noninvasive probing of tissue perfusion, and in terms of pressure autoregulation of organ blood flow, the regulation mechanism of internal organs seems to be closer to that of skeletal muscle than that of the brain. non-visceral vital organs.
- the present invention unexpectedly uses skeletal muscle as a potential substitute for monitoring gastrointestinal tissue, and preferably uses a management device with its own judgment function to non-invasively measure muscle tissue oxygen saturation (SmtO 2 , its essence above is a measure of the balance between oxygen supply and rate of consumption in muscle tissue), along with continuous monitoring of blood pressure and cardiac output, unexpectedly found that:
- the intraoperative management guided by muscle SmtO 2 can effectively treat the decrease of SmtO 2 , and to some extent, it can reduce the incidence of 24-hour PONV after laparoscopic hysterectomy;
- muscle SmtO2 - guided management can significantly reduce the incidence of 24-hour PONV after laparoscopic hysterectomy, and the incidence of PONV decreased from 41.3% in the routine management group to the SmtO2 - guided management group 24.0%.
- Fig. 1 is a flow chart of the intervention management program guided by SmtO2 monitoring in the embodiment.
- Figure 2 is the therapeutic efficacy of the Examples based on SmtO2 AUC below target.
- Fig. 3 is a comparison of the differences in the 24-hour PONV rate among the groups of patients whose PONV risk ratio BMI ⁇ 25 in the pre-specified subgroup of the example.
- FIG. 4 is a schematic structural diagram of the perioperative management device in Embodiment 1.
- FIG. 4 is a schematic structural diagram of the perioperative management device in Embodiment 1.
- a perioperative management device as shown in Figure 4, comprising: a signal acquisition module 1, a data processing module 2 and a display module 3;
- the signal collection module 1 is used to collect the sign signals of the managed objects: muscle tissue oxygen signals and hemodynamic sign signals;
- the data processing module 2 is connected with the signal acquisition module 1, and is used for receiving and processing the sign signal of the managed object, so as to convert it into sign parameters, and obtain muscle tissue oxygen parameters and hemodynamic parameters.
- the data processing module 2 can store or can be input with reference parameters for comparing one or more of the sign parameters with their reference parameters. That is, the data processing module is used to analyze the relationship between the muscle tissue oxygen parameter, the hemodynamic parameter and the baseline value of each parameter or the area under the target curve. Through the analysis result of the data processing module, it is judged whether to enter the management mode or enter the next parameter judgment mode.
- the display module 3 is connected with the data processing module 2, and is used for displaying the visualized data output by the data processing module.
- muscle tissue oxygen is selected from flank SmtO 2 and forearm SmtO 2 .
- ⁇ cardiac output
- BP blood pressure
- determinants of cardiac output include stroke rate (SV) and heart rate (HR).
- Determinants of blood pressure include cardiac output and systemic vascular resistance (SVR).
- the signal collection module 1 includes: a signal collector 11, configured to collect the sign signal of the subject.
- the signal collector includes sensors that directly collect the sign signal.
- the signal collector 11 includes a first signal collector 111, a second signal collector 112, a third signal collector 113, a fourth signal collector 114 and a fifth signal collector 115; the first signal collector 111 is used for Collect flank SmtO 2 , the second signal collector 112 is used to collect forearm SmtO 2 , the third signal collector 113 is used to collect blood pressure signals, the fourth signal collector 114 is used to collect stroke rate (SV), and the fifth signal The collector 115 is used to collect heart rate (HR).
- the data processing module 2 includes a signal processor for receiving and processing the signals collected by the sensors in the signal collector.
- the data processing module 2 includes a muscle tissue oxygen data processing module 21 and a hemodynamic parameter data processing module 22 connected to the muscle tissue oxygen data processing module.
- the signal processor includes a first signal processor 211 and a second signal processor 221, the first signal processor is set in the muscle tissue oxygen data processing module, and the second signal processor is set in the hemodynamic parameter data processing module.
- the first signal processor is used to convert the muscle tissue oxygen signal of the managed subject into corresponding parameters
- the second signal processor is used to convert the hemodynamic parameter signal of the managed subject into corresponding parameters.
- Muscle tissue oxygen data processing module 21 comprises side abdomen SmtO 2 data processing modules and forearm SmtO 2 data processing modules juxtaposed; when the SmtO in at least one data processing module monitoring value ⁇ 70% or lower than its baseline value (preferably in two whichever is higher), and the duration is ⁇ 60s, then start to enter the hemodynamic parameter data processing module; if not, keep the continuous monitoring state.
- the hemodynamic parameter data processing module 22 includes a sequentially connected cardiac output data processing module, a systemic vascular resistance data processing module and a blood pressure data processing module.
- a systemic vascular resistance data processing module When the relationship between the monitoring value and the preset value of the parameter is judged as “No”, it prompts to enter the next parameter judgment mode; when it is "Yes”, it prompts to enter the management mode. "No” can be divided into two situations: reaching the preset value and not reaching the preset value, which mainly depends on the sign parameters to be judged.
- the cardiac output data processing module includes a parallel and interconnected heart rate data processing module and a beat rate data processing module.
- the beat rate data processing module includes parallel preload data processing module, afterload data processing module and contraction force data processing module, and the preload data processing module and afterload data processing module are respectively connected with the contraction force data processing module.
- the monitoring value of the cardiac output data processing module when the monitoring value of the cardiac output data processing module reaches the baseline value of the parameter, it prompts to check the stroke rate data processing module. When the monitoring value of the cardiac output data processing module does not reach the baseline value of the parameter, it prompts to enter the preload data processing module or the afterload data processing module. Further, when the monitoring value of the current load data processing module or the afterload data processing module does not reach the baseline value or scalar difference of the parameter, it prompts to enter the contraction force data module; when the baseline value or scalar difference of the parameter is reached , prompts to enter management mode.
- connection between the above modules is a wired connection or a wireless connection.
- the display module 3 includes a touch screen 8 providing a display interface and a display controller 7, the display controller 7 is used to display and/or update control output visual graphics, text, pictures, etc.
- the management device includes: a central processing unit 4, which is used as the final processing and execution unit for data processing and each module;
- One or more memory 5 the above-mentioned modules can be respectively placed in different memories; each module stored in the memory is operated or executed by the central processing unit to perform various functions of the device and process data;
- the communication module 9 is used to receive the communication signal and convert it into an electrical signal, and convert the electrical signal into a communication signal before sending it; select component modules known in the art, and use any communication standard, protocol, etc. Wireless communication; the management device can communicate with external networks or other devices through the communication module;
- the power supply system 10 provides power for each module, component or circuit in the management device
- the peripheral interface 6 is respectively connected with the central processing unit, the signal collector, the communication module and the display controller.
- the physical condition belongs to the physical condition class I-III stipulated by the American Society of Anesthesiologists (ASA);
- Severe neurological, cognitive or psychological diseases stroke with neurological deficits, dementia, schizophrenia or any disease that is unlikely to have meaningful postoperative follow-up;
- Severe cardiovascular disease low output heart failure (defined as preoperative left ventricular ejection fraction ⁇ 30%), active coronary artery disease, symptomatic valvular disease with or without pacemaker and/or automatic Symptomatic arrhythmias in implantable cardioverter-defibrillators (AICDs);
- AICDs implantable cardioverter-defibrillators
- COPD chronic obstructive pulmonary disease
- Muscle diseases such as malnutrition, atrophy and weakness
- Intervention group Patients received SmtO 2 -guided management during surgery in addition to routine management.
- Control group patients only received routine management during the operation.
- Example 2 The device of Example 1 is distributed, connected and activated in the operating room 15-30 minutes before the arrival of the patient.
- Example 3 The device of Example 1 will be used to monitor tissue oxygenation at two different locations. Data will be collected by the anesthetist (for the intervention group) for intraoperative management.
- Baseline measurements in both groups: before induction of anesthesia and in the patient's calm and breathing air, baseline flank SmtO 2 , forearm SmtO 2 , BP (blood pressure), CI (cardiac index), stroke rate (SV), heart rate (HR) and systemic vascular resistance (SVR) will be measured and recorded as baseline values. Judgment must be exercised to ensure that the recorded measurements are reliable. For example, BP measurements will be repeated if necessary until reliable values are obtained. Judgments of reliability must take into account the patient's age, previous measurements, and medical and physical condition. Mild sedation, such as 10-20 mg propofol or 1-4 mg midazolam, can be used for light sedation when needed to calm the patient and obtain correct baseline values.
- Control group The screens of the management device will be covered so that they cannot be read by the anesthesiologist.
- Intervention group anesthesiologists will use the management device to monitor and perform intraoperative management.
- the first step is to check CO when SmtO2 is below target.
- SVV SV change
- ⁇ SV subsequent SV monitoring value - prior SV monitoring value
- the ⁇ SV was assessed by giving the patient 250 mL of Lactated Ringer (LR) over 2-3 minutes to determine the difference in SV before and after the bolus injection. If SVV>12% or ⁇ SV ⁇ 10%, that is, the patient may be sensitive to fluid, a fluid bolus (250ml LR) can be performed and rechecked. Repeat until SVV ⁇ 12% or ⁇ SV ⁇ 10%. These percentages are indicative values only.
- Perioperative management will be in line with current management standards at the investigation site.
- ⁇ Clear fluids may be received within 2 hours of induction, except in patients with severe gastroesophageal reflux disease (GERD) or symptomatic gastroparesis
- GFD gastroesophageal reflux disease
- Sufentanil is intravenously injected, and the dose is based on clinical judgment
- Laboratory test results include hemoglobin, hematocrit and creatinine.
- 24-h PONV rate 24-h PONV was defined as nausea, vomiting or vomiting within 24 h after surgery.
- NRS Numeric Rating Scale
- Quality of recovery in the first 24 hours after surgery measured by a 15-item quality-recovery scale (QoR-15);
- Comparisons of perioperative characteristics and outcomes were performed using independent t-tests or Wilcoxon rank-sum tests, chi-square tests, or Fisher's exact tests. Prespecified subgroup analyzes and a series of sensitivity analyzes for the primary outcome were performed. Statistical analysis was performed using the R (version 3.5.2) package including arsenal, fmsb and sjstats. A P2 value of less than 0.05 was considered statistically significant for the primary outcome.
- the efficacy of SmtO2 - guided intraoperative management was assessed using the following target AUC.
- the abscissa and ordinate are the operation time and the difference between SmtO2 and the intended target, respectively.
- the zero point on the ordinate indicates the SmtO2 treatment target, i.e., baseline or 70% AUC area, whichever is higher.
- Sequential traces of SmtO2 forearm of patients from the SmtO2 - guided treatment group (A) and usual management group (B) are illustrated.
- SmtO2 measurements that are higher than the target are shown in red (the part of the area above the 0 point on the ordinate), while those that are equal to or less than the target are shown in blue (the part of the area below the 0 point on the ordinate).
- the AUC below the target is indicated in blue.
- Serial lateral (C and D) and forearm (E and F) SmtO traces from patients in the SmtO guided management group (C and E) and usual management group (D and F) are plotted on the same axis to form the AUC from different patients overlap each other. Median SmtO 2 AUC measured at different locations and different treatment groups is shown.
- SmtO 2 represents muscle tissue oxygen saturation; AUC represents the area under the curve.
- the 24-hour PONV rates of patients with a hazard ratio of PONV in prespecified subgroups with a BMI (weight in kilograms divided by height in meters squared) ⁇ 25 were significantly different between groups. Differences (p ⁇ 0.001), p-values remained significant after adjustment for multiple comparisons. After adjustment for multiple comparisons, there was no statistically significant between-group difference in 24-hour PONV rates among patients with baseline hemoglobin levels ⁇ 126 g/L.
- SmtO 2 means muscle tissue oxygen saturation
- PONV means postoperative nausea and vomiting
- IQR means interquartile range
- AUC means area under the curve and NA means not applicable.
- ASA Physical status criteria for ASA include categories of normal health (I), mild systemic disease (II) and severe systemic disease (III).
- SmtO 2 represents oxygen saturation of muscle tissue, IQR interquartile range and AUC area under the curve.
- the p-value was not significant
- SmtO2 indicates muscle tissue oxygen saturation
- PONV indicates postoperative nausea and vomiting
- IQR indicates interquartile range
- AUC indicates area under the curve and NA indicates not applicable.
- NRS Numeric Rating Scale
- iIleus occurred in 1 patient in the usual management group.
- jDeep vein thrombosis occurred in 1 patient in the SmtO2 - guided treatment group and in 2 patients in the usual care group.
- One patient in the SmtO2 - guided management group had a urinary tract infection; one patient in the SmtO2 - guided treatment group had a surgical site infection, and three patients in the usual care group had a surgical site infection.
- SmtO 2 represents oxygen saturation of muscle tissue, IQR interquartile range and AUC area under the curve.
- SmtO2 indicates muscle tissue oxygen saturation
- PONV indicates postoperative nausea and vomiting
- IQR indicates interquartile range
- AUC indicates area under the curve and NA indicates not applicable.
- NRS Numeric Rating Scale
- the p value is not significant
- iDeep vein thrombosis occurred in 1 case in the SmtO 2 -guided treatment group and 1 case in the usual treatment group.
- Nausea is defined as a subjective feeling of discomfort associated with the desire to vomit. Nausea should be assessed by the patient rather than the observer. This feeling is best described as a desire to vomit without vigorous muscle movement.
- Gagging is defined as laborious, spastic, and rhythmic contractions of the pectoral and abdominal muscles without expulsion of gastric contents. The difference between gagging and vomiting is that even the smallest amount of stomach contents is produced. If the contents of the stomach are not expelled, the expulsion effort is classified as gagging. Nausea usually indicates an empty stomach and usually makes the patient uncomfortable.
- Vomiting is the forcible expulsion of any stomach contents from the mouth.
- PONV refers to the occurrence of nausea, gagging and/or vomiting.
- ⁇ PONV will be assessed at 2, 6, and 24 hours postoperatively (3 times).
- ⁇ 24-hour PONV was defined as the incidence of PONV within 24 hours after surgery.
- NRS Numeric Rating Scale
- the outcome assessor should call the patient specifically to evaluate PONV.
- the primary endpoint was the rate of PONV within 24 hours of surgery.
- the same NRS (0-10 scale, where 0 represents no pain and 10 represents the worst pain) used for nausea assessment will be used to assess pain severity.
- the quality of the first night's sleep after surgery will be rated using the 0-10 NRS (0 being the worst sleep and 10 being the best sleep)
- ⁇ Ambulation was defined as the patient's ability to get out of bed and walk with or without assistance.
- ⁇ Recovery of gastrointestinal function is indicated by the ability to tolerate food in the mouth (tolerance).
- Gastrointestinal-related complications include ileus, obstruction, perforation, and hemorrhage. It is defined as follows.
- Ileus is a temporary cessation of bowel movement. Symptoms and signs of intestinal obstruction include bloating, nausea, vomiting, and vague discomfort. Pain rarely has the classic colic pattern in mechanical obstruction. May have constipation or pass light watery stools. Auscultation revealed silent or minimal abdominal movements. The abdomen is not tender unless the underlying cause is inflammation. Bowel obstruction most often occurs after abdominal surgery, especially after the bowel has been manipulated. Symptoms are nausea, vomiting, and vague abdominal discomfort. Diagnosis is based on X-ray findings and clinical impressions. Supportive treatment with nasogastric aspirates and intravenous fluids.
- Ileus is severe mechanical injury or intestinal obstruction due to pathological causes that completely prevents the passage of contents through the intestinal tract. Symptoms include cramping, vomiting, constipation and flatulence. Diagnosis is clinical and confirmed by abdominal radiography. Treatment includes fluid resuscitation, nasogastric aspiration, and in most cases surgery for complete obstruction.
- Perforation may occur in any part of the GI tract, releasing gastric or intestinal contents into the peritoneal space. There are various reasons. Symptoms come on suddenly, with severe pain, followed by signs of shock shortly after. Diagnosis is usually made by finding free air in the abdomen on imaging studies. Treatment includes fluid resuscitation, antibiotics, and surgery. Mortality is high and depends on the underlying disease and the patient's general health.
- Gastrointestinal bleeding can originate anywhere from the mouth to the anus and may be overt or insidious. Manifestations depend on the site and frequency of bleeding.
- KDIGO defines acute kidney injury as any of the following:
- Serum creatinine increased to 1.5 times baseline or more within the last 7 days, or
- ⁇ Severe sepsis/septic shock two or more of standard systemic inflammatory response syndrome, known infection and new-onset dysfunction of at least one system or need for vasopressors to maintain blood pressure
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Abstract
A perioperative-period management apparatus and method based on muscle tissue oxygen monitoring, and the application thereof. The management apparatus comprises: an information collection module, a data processing module and a display module, wherein the information collection module is used for collecting physical sign information, such as muscle tissue oxygen information and hemodynamic physical sign information, of an object for management; and the data processing module is connected to the information collection module, and is used for receiving and processing the physical sign information of the object of management, so as to convert the physical sign information into physical sign parameters, such as a muscle tissue oxygen parameter and a hemodynamic parameter. During management, a management mode is selected according to a comparison between one or more monitored physical sign parameters and a reference parameter. By means of a perioperative-period data management, processing and analysis method based on muscle tissue oxygen monitoring, the improvement of management during the perioperative period is facilitated, thereby effectively treating the decrease in SmtO2; and the occurrence rate of PONV within 24 hours after a laparoscopic hysterectomy can be decreased by a certain extent.
Description
本发明属于管理医疗方法领域，具体涉及一种基于肌肉组织氧监测的围手术期用管理装置、方法及其应用。The invention belongs to the field of management medical methods, and in particular relates to a perioperative management device, method and application thereof based on muscle tissue oxygen monitoring.
众所周知，手术可以治愈病痛，但同时也存在一定的风险性。手术的治疗效果常常被各种并发症最小化或无效，有时手术弊大于利。围手术期出现的各种并发症仍然普遍存在，如术后恶心和呕吐(PONV)、胃肠道出血、肠梗塞、吻合口破裂、急性肾损伤、术后感染、术后出血等症状会在一定程度上影响患者的恢复，甚至威胁患者的生命。因此，提升围手术期管理质量是一项不容忽视的任务。As we all know, surgery can cure pain, but it also has certain risks. The therapeutic effect of surgery is often minimized or ineffective by various complications, and sometimes surgery does more harm than good. Various complications in the perioperative period are still prevalent, such as postoperative nausea and vomiting (PONV), gastrointestinal bleeding, intestinal infarction, anastomotic rupture, acute kidney injury, postoperative infection, postoperative bleeding and other symptoms will occur in the To a certain extent, it affects the recovery of the patient, and even threatens the life of the patient. Therefore, improving the quality of perioperative management is a task that cannot be ignored.
在术后不良事件和并发症中，术后恶心和呕吐(PONV)是患者最为困扰的问题之一。尽管现代医学已采用了各种预防措施，但PONV的患病率仍保持在50％或更高。PONV不仅会给患者带来不适，存在引起术后并发症的风险，还可能会延长患者住院期、增加医疗费用。现有研究表明，在多种引发PONV的危险因素中，组织灌注不足，尤其是胃肠道组织灌注可能是PONV的潜在原因之一。但是，这种推测尚未得到充分研究。因此，如何降低PONV的患病率成为亟待解决的技术问题。Among postoperative adverse events and complications, postoperative nausea and vomiting (PONV) is one of the most troubling issues for patients. Despite various preventive measures adopted by modern medicine, the prevalence of PONV remains at 50% or higher. PONV not only brings discomfort to patients, but also has the risk of postoperative complications, and may prolong the hospital stay and increase medical expenses. Existing studies have shown that among various risk factors for PONV, tissue hypoperfusion, especially gastrointestinal tissue perfusion, may be one of the potential causes of PONV. However, this speculation has not been fully studied. Therefore, how to reduce the prevalence of PONV has become an urgent technical problem to be solved.
发明内容Contents of the invention
本发明提供一种围手术期用管理装置，包括：信息采集模块、数据处理模块和显示模块；The present invention provides a perioperative management device, comprising: an information collection module, a data processing module and a display module;
所述信息采集模块用于采集管理对象的体征信息(所述信息可以为信号)，例如肌肉组织氧信息和/血流动力学体征信息；The information collection module is used to collect sign information (the information may be a signal) of the managed object, such as muscle tissue oxygen information and/hemodynamic sign information;
所述数据处理模块与信息采集模块连接，其用于接收与处理管理对象的体征信息，以使其转化为体征参数，例如肌肉组织氧参数和血流动力学参数。The data processing module is connected with the information collection module, which is used to receive and process the sign information of the management object, so as to convert it into sign parameters, such as muscle tissue oxygen parameters and hemodynamic parameters.
优选地，所述数据处理模块还可以将所述体征参数中的一种或多种与参比参数进行比较。Preferably, the data processing module can also compare one or more of the physical sign parameters with reference parameters.
优选地，所述数据处理模块能够存储或可被输入参比参数。Preferably, said data processing module is capable of storing or can be input with reference parameters.
优选地，通过所述数据处理模块来分析肌肉组织氧参数、血流动力学参数与各参数基线值或者目标曲线下面积之间的关系。Preferably, the data processing module is used to analyze the relationship between the muscle tissue oxygen parameter, the hemodynamic parameter and the baseline value of each parameter or the area under the target curve.
优选地，通过所述数据处理模块的分析结果，确定是否进入管理模式或进入下一参数判断模式。Preferably, according to the analysis result of the data processing module, it is determined whether to enter the management mode or enter the next parameter judgment mode.
所述显示模块与数据处理模块连接，用于显示数据处理模块输出的可视化数据。The display module is connected with the data processing module, and is used for displaying the visualized data output by the data processing module.
根据本发明的实施方案，所述肌肉组织氧(SmtO
2)选自侧腹SmtO
2和/或前臂SmtO
2。
According to an embodiment of the present invention, the muscle tissue oxygen (SmtO 2 ) is selected from flank SmtO 2 and/or forearm SmtO 2 .
根据本发明的实施方案，所述血流动力学体征包括心排量(CO)和血压(BP)。其中，所述心排量的决定因素包括每搏率(SV)和心率(HR)。所述血压的决定因素包括心排量和***性血管阻力(SVR)。According to an embodiment of the invention, said hemodynamic signs include cardiac output (CO) and blood pressure (BP). Wherein, the determinants of cardiac output include stroke rate (SV) and heart rate (HR). The determinants of blood pressure include cardiac output and systemic vascular resistance (SVR).
根据本发明的实施方案，所述信息采集模块含有信号采集模块，所述信息采集模块包含信号采集模块，所述信号采集模块用于采集管理对象的体征信号，例如肌肉组织氧信号和/或血流动力学体征信号。According to an embodiment of the present invention, the information collection module includes a signal collection module, and the information collection module includes a signal collection module, and the signal collection module is used to collect the sign signal of the managed object, such as muscle tissue oxygen signal and/or blood Fluid signs.
根据本发明的实施方案，所述信息采集模块或信号采集模块包括信号采集器，用于采集对象的体征信号，例如肌肉组织氧信号和/或血流动力学体征信号。According to an embodiment of the present invention, the information collection module or signal collection module includes a signal collector for collecting a sign signal of the subject, such as a muscle tissue oxygen signal and/or a hemodynamic sign signal.
例如，所述信号采集器包括用于第一信号采集器、第二信号采集器、第三信号采集器、第四信号采集器和/或第五信号采集器；For example, the signal collector includes a first signal collector, a second signal collector, a third signal collector, a fourth signal collector and/or a fifth signal collector;
所述第一信号采集器用于采集侧腹SmtO
2，所述第二信号采集器用于采集前臂SmtO
2，所述第三信号采集器用于采集血压信号，所述第四信号采集器用于采集每搏率(SV)，所述第五信号采集器用于采集心率(HR)。
The first signal collector is used to collect flank SmtO 2 , the second signal collector is used to collect forearm SmtO 2 , the third signal collector is used to collect blood pressure signals, and the fourth signal collector is used to collect heart rate (SV), the fifth signal collector is used to collect heart rate (HR).
根据本发明的实施方案，所述信号采集器包括直接采集体征信号的传感器。According to an embodiment of the present invention, the signal collector includes a sensor that directly collects the sign signal.
根据本发明的实施方案，所述数据处理模块包括信号处理器，用于接收与处理信号采集器中传感器采集的信号。According to an embodiment of the present invention, the data processing module includes a signal processor for receiving and processing the signal collected by the sensor in the signal collector.
根据本发明的实施方案，所述数据处理模块包括肌肉组织氧数据处理模块和与肌肉组织氧数据处理模块连接的血流动力学参数数据处理模块。According to an embodiment of the present invention, the data processing module includes a muscle tissue oxygen data processing module and a hemodynamic parameter data processing module connected with the muscle tissue oxygen data processing module.
优选地，所述信号处理器包括第一信号处理器和第二信号处理器，所述第一信号处理器设置在肌肉组织氧数据处理模块中，所述第二信号处理器设置在血流动力学参数数据处理模块。其中，第一信号处理器用于将管理对象的肌肉组织氧信号转化为对应的参数，第二信号处理器用于将管理对象的血流动力学参数信号转化为对应的参数。Preferably, the signal processor includes a first signal processor and a second signal processor, the first signal processor is set in the muscle tissue oxygen data processing module, and the second signal processor is set in the hemodynamic Learning parameter data processing module. Wherein, the first signal processor is used to convert the muscle tissue oxygen signal of the managed subject into corresponding parameters, and the second signal processor is used to convert the hemodynamic parameter signal of the managed subject into corresponding parameters.
优选地，所述肌肉组织氧数据处理模块包括并列的侧腹SmtO
2数据处理模块和前臂SmtO
2数据处理模块；当至少一个数据处理模块中的SmtO
2监测值<70％(低于目标曲线下面积(AUC)值)或低于其基线值(优选以二者数值中的较高者为准)，并持续时间≥60s时，则开始进入血流动力学参数数据处理模块；若否，则保持继续监测状态。
Preferably, the muscle tissue oxygen data processing module includes side abdomen SmtO 2 data processing modules and forearm SmtO 2 data processing modules; when the SmtO 2 monitoring value in at least one data processing module<70% (lower than the target curve Area (AUC) value) or lower than its baseline value (preferably the higher of the two values) for a duration ≥ 60s, start to enter the hemodynamic parameter data processing module; if not, then Keep monitoring.
优选地，所述血流动力学参数数据处理模块包括顺次连接的心排量数据处理模块、***性血管阻力数据处理模块和血压数据处理模块。当监测值与该参数的预设数值之间的关系判断为“否”时，则提示进入下一参数判断模式；当为“是”时，则提示进入管理模式。其中的“否”分为达到预设数值和未达到预设数值两种情况，主要取决于待判断的体征参数。Preferably, the hemodynamic parameter data processing module includes a sequentially connected cardiac output data processing module, a systemic vascular resistance data processing module, and a blood pressure data processing module. When the relationship between the monitoring value and the preset value of the parameter is judged as "No", it prompts to enter the next parameter judgment mode; when it is "Yes", it prompts to enter the management mode. "No" can be divided into two situations: reaching the preset value and not reaching the preset value, which mainly depends on the sign parameters to be judged.
进一步优选地，所述心排量数据处理模块包括并列且互连的心率数据处理模块和每搏率数据处理模块。其中，所述每搏率数据处理模块包括并列的前负荷数据处理模块、后负荷数据处理模块和收缩力数据处理模块，前负荷数据处理模块和后负荷数据处理模块分别与收缩力数据处理模块连接。Further preferably, the cardiac output data processing module includes a parallel and interconnected heart rate data processing module and a beat rate data processing module. Wherein, the beat rate data processing module includes parallel preload data processing module, afterload data processing module and contraction force data processing module, and the preload data processing module and afterload data processing module are respectively connected with the contraction force data processing module .
其中，当所述心排量数据处理模块的监测值达到该参数的基线值时，则提示查看每搏率数据处理模块。当所述心排量数据处理模块的监测值未达到该参数的基线值时，则提示进入前负荷数据处理模块或后负荷数据处理模块。进一步地，当所述前负荷数据处理模块或后负荷数据处理模块的监测值未达到该参数的基线值或者标量差值时，则提示进入收缩力数据模块；当达到该参数的基线值或者标量差值时，则提示进入管理模式。Wherein, when the monitoring value of the cardiac output data processing module reaches the baseline value of the parameter, it prompts to check the beat rate data processing module. When the monitoring value of the cardiac output data processing module does not reach the baseline value of the parameter, it prompts to enter the preload data processing module or the afterload data processing module. Further, when the monitoring value of the preload data processing module or afterload data processing module does not reach the baseline value or scalar difference of the parameter, it prompts to enter the contraction force data module; when the baseline value or scalar value of the parameter is reached When the value is different, it prompts to enter the management mode.
当各个血流动力学参数数据处理模块均完成判断，而判断依旧为“否”时，则提示观察肌肉组织氧数据处理模块。When each hemodynamic parameter data processing module completes the judgment, and the judgment is still "No", it prompts to observe the muscle tissue oxygen data processing module.
根据本发明的实施方案，所述管理装置还包括中央处理器和/或一个或多个存储器，所述中央处理器作为数据接收、处理及各模块的最终处理、执行单元，所述存储器用于放置上述各模块。优选地，所述中央处理器可以由一个或多个处理器构成。由中央处理器运行或执行存储在存储器中的各个模块，以执行装置的各种功能和处理数据。According to an embodiment of the present invention, the management device further includes a central processing unit and/or one or more memories, the central processing unit is used as data receiving, processing and final processing and execution unit of each module, and the memory is used for Place the above modules. Preferably, the central processing unit may be composed of one or more processors. The various modules stored in the memory are run or executed by the central processing unit to perform various functions of the device and process data.
根据本发明的实施方案，上述各模块之间的连接可以为有线连接和/或无线连接，例如无线连接可以为云连接。According to the embodiment of the present invention, the connection between the above modules may be a wired connection and/or a wireless connection, for example, the wireless connection may be a cloud connection.
根据本发明的实施方案，所述显示模块包括提供显示界面的显示屏，显示屏可以为触摸式或非触摸式。According to an embodiment of the present invention, the display module includes a display screen providing a display interface, and the display screen may be touch-type or non-touch-type.
根据本发明的实施方案，所述显示模块还包括显示控制器，用于将控制输出的可视化图形、文字、 图片等的显示和/或更新。According to an embodiment of the present invention, the display module further includes a display controller, configured to control the display and/or update of output visual graphics, text, pictures, and the like.
根据本发明的实施方案，所述管理装置还包括通讯模块，用于接受通讯信号并将其转化为电信号，以及将电信号转化为通讯信号后发送。According to an embodiment of the present invention, the management device further includes a communication module, configured to receive communication signals and convert them into electrical signals, and convert the electrical signals into communication signals before sending them.
优选地，所述通讯模块可以选自本领域已知组件模块。优选地，所述通讯模块可以使用通信标准、协议等中的任意一种，例如包括但不限于利用有线媒介或无线媒介进行通讯，比如蓝牙、以太网或其他无线协议。Preferably, the communication module can be selected from component modules known in the art. Preferably, the communication module can use any one of communication standards, protocols, etc., including but not limited to using wired media or wireless media for communication, such as Bluetooth, Ethernet or other wireless protocols.
优选地，所述管理装置可以通过通讯模块与外部网络或其他设备进行通讯连接。Preferably, the management device can communicate with an external network or other devices through a communication module.
根据本发明的实施方案，所述管理装置还可以包括电源***，为装置中的各模块、元件或电路提供电力。According to an embodiment of the present invention, the management device may further include a power supply system to provide power for each module, element or circuit in the device.
根据本发明的实施方案，所述管理装置还包括外设接口，与中央处理器、信号采集器、通讯模块、显示控制器等分别连接。According to an embodiment of the present invention, the management device further includes a peripheral interface, which is respectively connected to the central processing unit, the signal collector, the communication module, the display controller, and the like.
本发明还提供一种生理参数或生理数据(例如围手术期生理参数或生理数据)的管理方法，包括使用上述围手术期管理装置处理围手术期生理参数或生理数据。The present invention also provides a management method of physiological parameters or physiological data (such as perioperative physiological parameters or physiological data), including using the above-mentioned perioperative management device to process perioperative physiological parameters or physiological data.
本发明还提供一种生理参数或生理数据(例如围手术期生理参数或生理数据)的分析方法，包括使用上述围手术期管理装置分析围手术期生理参数或生理数据。The present invention also provides a method for analyzing physiological parameters or physiological data (such as perioperative physiological parameters or physiological data), including using the above-mentioned perioperative management device to analyze perioperative physiological parameters or physiological data.
本发明还提供一种围手术期管理方法，包括如下步骤：The present invention also provides a perioperative management method, comprising the following steps:
在手术前获取处于清醒状态的管理对象的肌肉组织氧(SmtO
2)、心排量(CO)和血压(BP)的基线测量值，以得到各监测指标的基线值；
Obtain the baseline measurement values of muscle tissue oxygen (SmtO 2 ), cardiac output (CO) and blood pressure (BP) in awake subjects before the operation, so as to obtain the baseline values of each monitoring index;
优选地，测定基线值的时候，管理对象处于清醒，平静，没有焦虑，平躺，眼睛微闭状态，没有禁饮禁食，饭后约1-2个小时，没有肠道准备，没有脱水，没有急性疾病，没有疼痛，平静呼吸空气；Preferably, when the baseline value is measured, the subject is awake, calm, without anxiety, lying flat, with eyes slightly closed, without fasting, about 1-2 hours after a meal, without bowel preparation, and without dehydration. No acute illness, no pain, calm breathing air;
手术过程中监测肌肉SmtO
2监测值<70％(或者75％)或低于其基线值(优选以二者数值中的较高者为准)，并持续时间≥60s时，则开始进行干预治疗，以使管理对象的心排量(CO)和血压(BP)维持在正常范围；
During the operation, when the monitoring value of muscle SmtO 2 is <70% (or 75%) or lower than its baseline value (preferably whichever is higher in the two values), and the duration is ≥60s, the intervention treatment will be started , so that the cardiac output (CO) and blood pressure (BP) of the managed subjects can be maintained in the normal range;
若干预治疗后，肌肉SmtO
2监测值仍未落入上述范围内时，则开始排查其他因素，针对排查得到的影响因素进行干预管理；
If after the intervention treatment, the muscle SmtO 2 monitoring value still does not fall within the above range, start to check other factors, and carry out intervention management based on the influencing factors obtained from the check;
当所有可能影响因素均排查完成后，肌肉SmtO
2监测值依旧未落入上述范围内，则考虑开启下一个循环管理。
When all possible influencing factors have been checked and the muscle SmtO 2 monitoring value still does not fall within the above range, consider starting the next cycle of management.
根据本发明的实施方案，所述管理方法包括如下步骤：According to an embodiment of the present invention, the management method includes the following steps:
(1)在术前获取处于清醒状态的管理对象的肌肉组织氧(SmtO
2)和血流动力学体征的基线测量值，以得到各监测指标的基线值；
(1) Obtain the baseline measurement values of muscle tissue oxygen (SmtO 2 ) and hemodynamic signs of the subjects in an awake state before the operation, so as to obtain the baseline values of each monitoring index;
优选地，测定基线值的时候，管理对象处于清醒，平静，没有焦虑，平躺，眼睛微闭的状态，没有禁饮禁食，饭后约1-2个小时，没有肠道准备，没有脱水，没有急性疾病，没有疼痛，平静呼吸空气；Preferably, when the baseline value is measured, the subject is awake, calm, without anxiety, lying flat, eyes slightly closed, not fasting, about 1-2 hours after a meal, no bowel preparation, and no dehydration , no acute illness, no pain, calm breathing air;
所述肌肉组织氧(SmtO
2)包括侧腹SmtO
2、以及前臂SmtO
2或者下肢SmtO
2；
The muscle tissue oxygen (SmtO 2 ) includes flank SmtO 2 , and forearm SmtO 2 or lower limb SmtO 2 ;
所述血流动力学体征包括CO和BP；所述CO包括每搏量(SV)、心率(HR)和***性血管阻力(SVR)；The hemodynamic signs include CO and BP; the CO includes stroke volume (SV), heart rate (HR) and systemic vascular resistance (SVR);
(2)在手术过程中持续监测管理对象的侧腹SmtO
2和前臂SmtO
2值：当上述至少一个部位中的SmtO
2监测值<70％或低于其基线值(优选以二者数值中的较高者为准)，并持续时间≥60s时，则开始进行干预治疗；若否，则保持继续监测状态；
(2) Continuously monitor the flank SmtO 2 and forearm SmtO 2 values of the subject during the operation: when the SmtO 2 monitoring value in at least one of the above-mentioned parts is <70% or lower than its baseline value (preferably the value of the two values whichever is higher), and the duration ≥ 60s, start intervention therapy; if not, keep monitoring;
(3)干预治疗时，先考察CO监测值与其基线值的关系：若CO监测值低于其基线值，则考察SV监测值与其基线值的关系、和/或HR监测值与其基线值的关系；若否，则考察SVR监测值与其基线值 的关系；(3) When intervening treatment, first investigate the relationship between the CO monitoring value and its baseline value: if the CO monitoring value is lower than its baseline value, then investigate the relationship between the SV monitoring value and its baseline value, and/or the relationship between the HR monitoring value and its baseline value ; If not, examine the relationship between the SVR monitoring value and its baseline value;
(4)当所述SV监测值小于其基线值时，则可以采取增加心肌前负荷、增强心肌收缩力和/或心肌减少后负荷的干预治疗方式；若否，则考察HR监测值与其基线值的关系；(4) When the SV monitoring value is lower than its baseline value, intervention treatment methods can be adopted to increase myocardial preload, enhance myocardial contractility and/or reduce myocardial afterload; if not, examine the HR monitoring value and its baseline value Relationship;
(5)当所述HR监测值小于其基线值时，则考虑进行恢复HR的干预；(5) When the HR monitoring value is lower than its baseline value, consider performing intervention to restore HR;
(6)当所述SVR监测值大于其基线值的80％时，则考虑进行降低SVR的干预；若否，则考察BP监测值与其基线值的关系；(6) When the SVR monitoring value is greater than 80% of its baseline value, then consider the intervention to reduce the SVR; if not, investigate the relationship between the BP monitoring value and its baseline value;
(7)当所述BP监测值低于其基线值的80％时，则考虑返回步骤(3)改善CO，和/或返回步骤(6)干预SVR；而当CO干预治疗后BP监测值得到改善，则不再需要治疗BP，只需重复(3)-(6)步骤即可；(7) When the BP monitoring value is lower than 80% of its baseline value, consider returning to step (3) to improve CO, and/or return to step (6) to intervene in SVR; and when the BP monitoring value is obtained after CO intervention treatment improvement, it is no longer necessary to treat BP, just repeat steps (3)-(6);
(8)若上述干预治疗后，肌肉SmtO
2监测值仍未落入上述范围内时，则开始排查其他因素，针对排查得到的结果进行干预管理；管理后，若肌肉SmtO
2监测值仍未落入上述范围内，则回到第(2)步。
(8) If after the above-mentioned intervention treatment, the muscle SmtO 2 monitoring value still does not fall within the above-mentioned range, start to investigate other factors, and carry out intervention management based on the results obtained from the investigation; after management, if the muscle SmtO 2 monitoring value still does not fall If it is within the above range, go back to step (2).
根据本发明的实施方案，步骤(1)中，需要保证所述基线值的准确性和可靠性，必要时可重复测量上述参数。According to the embodiment of the present invention, in step (1), it is necessary to ensure the accuracy and reliability of the baseline value, and the above parameters can be measured repeatedly if necessary.
根据本发明的实施方案，步骤(1)中，所述管理对象还应处于镇静状态，并能够呼吸室内空气。当管理对象表现出焦虑时，则对其进行轻度镇静；例如，可以对其施用异丙酚(例如用量为10-20mg)或咪达***(例如用量为1-4mg)。According to the embodiment of the present invention, in step (1), the managed subject should also be in a sedated state and be able to breathe indoor air. When the managed subjects show anxiety, they are lightly sedated; for example, propofol (for example, the dosage is 10-20 mg) or midazolam (for example, the dosage is 1-4 mg) can be administered to them.
根据本发明的实施方案，步骤(1)中，所述管理对象为普通外科手术患者，即接受中低风险外科手术的相对年轻和健康的患者。该管理对象通常没有重大的围手术期并发症，相反，当务之急是促进术后恢复。进一步地，所述管理对象能够拓宽到其他患者，包括高风险外科手术，高风险外科患者等。本发明没有对管理对象、手术和风险程度的限制。According to the embodiment of the present invention, in step (1), the management object is a general surgery patient, that is, a relatively young and healthy patient undergoing a medium-low risk surgery. This management usually has no major perioperative complications and, instead, the immediate priority is to facilitate postoperative recovery. Further, the management objects can be extended to other patients, including high-risk surgical operations, high-risk surgical patients, and the like. The present invention has no limitation on the subjects to be managed, the surgery and the degree of risk.
根据本发明的实施方案，步骤(1)中，所述管理对象为具有三个或三个以上PONV(术后恶心和呕吐)危险因素的患者，例如为女性、非吸烟状态且预期将接受阿片类镇痛的患者。进一步地，所述管理对象的身体状况属于美国麻醉师协会划分的I-III身体状况：正常健康分类(I)，轻度全身性疾病(II)和重度全身性疾病(III)。进一步地，对所述管理对象进行的手术为包括子宫切除术在内的选择性腹腔镜手术。进一步地，所述管理对象不包括计划进行***或开放式子宫切除术，紧急或紧急手术或涉及肠切除术的患者，也不包括患有重大全身合并症或在手术前3个月内接受过化学疗法或放射疗法的患者。According to an embodiment of the present invention, in step (1), the management object is a patient with three or more PONV (postoperative nausea and vomiting) risk factors, for example, is a female, non-smoking and is expected to receive opioids Analgesic patients. Further, the physical condition of the managed subject belongs to the I-III physical condition classified by the American Society of Anesthesiologists: normal health classification (I), mild systemic disease (II) and severe systemic disease (III). Further, the operation performed on the managed object is a selective laparoscopic operation including hysterectomy. Further, the management objects do not include patients who are planned to undergo vaginal or open hysterectomy, urgent or urgent surgery or involving bowel resection, nor do they have major systemic comorbidities or have received hysterectomy within 3 months before surgery Patients undergoing chemotherapy or radiation therapy.
根据本发明的实施方案，步骤(1)中，所述基线测量值可通过上述管理装置连接管理对象进行获取。例如，所述装置与管理对象的连接方式均为非侵入性连接。例如，在管理对象的左椎旁肌(垂直于L2-3水平对准脊柱)上放置一个探针，以监测侧腹SmtO
2，并在左前臂肱前臂肌(在肘前折痕下方约2个手指)上放置第二个探针，以监测前臂SmtO
2。例如，将该装置的指套套在管理对象的左手，以监测全身血流动力学，而右上臂通常将用于无创血压测量的臂套用于日常管理。
According to an embodiment of the present invention, in step (1), the baseline measurement value can be obtained by connecting the management object with the above-mentioned management device. For example, the connection modes between the device and the management object are all non-intrusive connections. For example, place a probe on the subject's left paraspinal muscle (aligned perpendicular to the spine at the L2-3 level) to monitor flank SmtO2 , and on the left forearm brachialis muscle (approximately 2 finger) to monitor SmtO 2 on the forearm. For example, a finger cuff of the device is worn on the subject's left hand to monitor systemic hemodynamics, while an arm cuff for non-invasive blood pressure measurement is typically used on the right upper arm for daily management.
根据本发明的实施方案，步骤(4)中，在考虑增加心肌前负荷时，需考察每搏量变异度(SVV)或每搏量增量(△SV，△SV＝在后每搏量监测值-在先每搏量监测值)值；优选地，当SVV>12％或△SV≥10％时，则对所述管理对象进行输液干预；若否，则考虑增加心肌收缩力。其中，所述输液干预为在2-3分钟内向管理对象静脉推注乳酸林格式液(LR，优选一次推注量为250毫升)，推注完成后并再次检查，直至SVV<12％或△SV<10％，或者SmtO
2监测值得到改善；进一步地，当重复次数达到6-8次时，SmtO
2监测值若无改善，则停止推注并咨询麻醉师以获取建议。
According to an embodiment of the present invention, in step (4), when considering increasing myocardial preload, it is necessary to examine stroke volume variability (SVV) or stroke volume increment (△SV, △SV=after stroke volume monitoring value-previous stroke volume monitoring value) value; preferably, when SVV>12% or △SV≥10%, then the management object is given infusion intervention; if not, the myocardial contractility is considered to be increased. Wherein, the infusion intervention is an intravenous bolus injection of Lactated Ringer’s solution (LR, preferably 250 ml in one bolus) to the management object within 2-3 minutes. After the bolus is completed, check again until SVV<12% or △ SV<10%, or the SmtO 2 monitoring value is improved; further, when the number of repetitions reaches 6-8 times, if the SmtO 2 monitoring value does not improve, stop the bolus injection and consult an anesthesiologist for advice.
根据本发明的实施方案，步骤(4)中，在考虑减少心肌后负荷时，需考察SVR监测值是否大于其基线值。当SVR监测值大于其基线值时，则可以考虑对管理对象进行止疼、避免低氧、避免高碳酸血症和/或扩展动脉血管的干预；若否，则考虑增加心肌收缩力。其中，止疼可以通过静脉推注舒芬太 尼来实现，其剂量基于临床判断；扩展动脉血管可以通过输注尼卡地平来实现。According to the embodiment of the present invention, in step (4), when considering reducing myocardial afterload, it is necessary to check whether the SVR monitoring value is greater than its baseline value. When the SVR monitoring value is greater than its baseline value, the management object can be considered for pain relief, avoiding hypoxia, avoiding hypercapnia, and/or intervention to expand arteries; if not, consider increasing myocardial contractility. Among them, pain relief can be achieved by intravenous injection of sufentanil, and the dose is based on clinical judgment; arterial expansion can be achieved by infusion of nicardipine.
根据本发明的实施方案，步骤(4)中，所述增加心肌收缩力的途径可以为输注多巴酚丁胺、增加钙离子(当钙离子浓度低时)和/或推注麻黄碱(当血压低时)。According to an embodiment of the present invention, in step (4), the way to increase myocardial contractility can be infusion of dobutamine, increase of calcium ion (when calcium ion concentration is low) and/or bolus injection of ephedrine ( when blood pressure is low).
根据本发明的实施方案，步骤(5)中，所述恢复HR的干预方式可以为施加小剂量的阿托品，例如静脉推注0.1-0.2mg；可在必要时重复进行。如果同时血压低，则可以使用麻黄碱(5-10毫克)作为替代品。广泛接受的HR范围是50-100bpm。但是，允许在此范围内微调HR。如果HR超出此范围，则需咨询高级麻醉师以获取建议。According to the embodiment of the present invention, in step (5), the intervention method for restoring HR may be to apply a small dose of atropine, for example, bolus injection of 0.1-0.2 mg intravenously; it can be repeated when necessary. If blood pressure is low at the same time, ephedrine (5-10 mg) can be used as a substitute. A widely accepted HR range is 50-100bpm. However, fine-tuning of HR within this range is allowed. If HR is outside this range, a senior anesthesiologist should be consulted for advice.
根据本发明的实施方案，步骤(6)中，所述降低SVR的干预方式可以为输注尼卡地平(例如输注量为1-5mg/h)，以使小动脉血管舒张。通过干预SVR，一方面可以提高心排量，另一方面可以通过降低血流阻力提高组织灌注。According to an embodiment of the present invention, in step (6), the intervention method for reducing SVR may be infusion of nicardipine (for example, the infusion amount is 1-5 mg/h), so as to dilate arterioles. By intervening in SVR, on the one hand, cardiac output can be increased, and on the other hand, tissue perfusion can be improved by reducing blood flow resistance.
根据本发明的实施方案，步骤(7)中，当所述BP监测值低于其基线值的80％、且CO高于其基线值时，则可以考虑使用去氧肾上腺素输注或麻黄碱推注的干预方式(原因：BP＝CO×SVR)；输注速率和推注剂量优选为临床上合适的输注速率和推注剂量。According to an embodiment of the present invention, in step (7), when the BP monitoring value is lower than 80% of its baseline value and the CO is higher than its baseline value, phenylephrine infusion or ephedrine can be considered The intervention mode of bolus (reason: BP=CO×SVR); the infusion rate and bolus dose are preferably clinically appropriate infusion rate and bolus dose.
而当CO稳定时，BP监测值低于其基线值的80％则很可能是由于SVR降低所致，可以采用施加血管加压药。When CO is stable, BP monitoring values below 80% of their baseline values are likely to be due to decreased SVR, and vasopressors can be used.
根据本发明的实施方案，步骤(7)中，所述其他因素包括动脉血氧含量低、肌肉代谢率高、腹内压高和/或肌肉受到压迫。According to an embodiment of the present invention, in step (7), the other factors include low arterial blood oxygen content, high muscle metabolic rate, high intra-abdominal pressure and/or muscle compression.
其中，当动脉血氧含量低时，检查是否存在脉氧监测值大于其基线值、吸入氧浓度低、和/或急性失血的情况。进一步地，当脉氧监测值大于其基线值时，针对病因进行施治；当吸入氧浓度低时，增加吸入氧浓度，维持正常状态(EtCO
2＝30-40mm Hg)；当急性失血时，采取输血措施，以维持动脉血氧饱和度(SpO
2)>95％，维持血红蛋白浓度>7-9g/dl。进一步地，当考察到血红蛋白浓度时，务必需要考虑血管内容量状态，因为血容量过低(血药浓度)会导致虚高的血红蛋白水平，只有当在纠正血容量不足后才显示血红蛋白水平低。
Wherein, when the arterial blood oxygen content is low, it is checked whether there is a pulse oximetry value greater than its baseline value, low inspired oxygen concentration, and/or acute blood loss. Further, when the pulse oxygen monitoring value is greater than its baseline value, treat the cause; when the inspired oxygen concentration is low, increase the inspired oxygen concentration to maintain a normal state (EtCO 2 =30-40mm Hg); when acute blood loss, Take blood transfusion measures to maintain arterial oxygen saturation (SpO 2 ) >95%, and maintain hemoglobin concentration >7-9g/dl. Further, when looking at hemoglobin concentrations, it is important to consider the intravascular volume status, since hypovolemia (plasma levels) can lead to falsely high hemoglobin levels, which are only revealed when the hypovolemia is corrected.
其中，当肌肉代谢率高时，检查是否存在体温>37℃或肌肉运动的情况。当体温>37℃时，采取降低体温治疗方式，使体温保持在36-37℃范围内；当肌肉运动时，需检查肌肉抽搐情况，并以临床上适当的方式使用肌肉松弛剂。Among them, when the muscle metabolic rate is high, check whether there is a body temperature > 37°C or muscle movement. When the body temperature is >37°C, hypothermia should be used to keep the body temperature in the range of 36-37°C; when muscles are in motion, muscle twitching should be checked and muscle relaxants should be used in a clinically appropriate manner.
其中，当腹内压高时，可充气使腹压≤10cm H
2O。
Among them, when the intra-abdominal pressure is high, it can be inflated to make the abdominal pressure ≤10cm H 2 O.
根据本发明的管理方法，其优选使用所述管理装置进行。According to the management method of the present invention, it is preferably performed using the management device.
本发明还提供上述装置或方法在抑制和/或治疗围手术期并发症的***中的应用。The present invention also provides the application of the above-mentioned device or method in a system for inhibiting and/or treating perioperative complications.
本发明还提供上述装置在处理、管理或分析围手术期生理参数或生理数据(例如围手术期生理参数或生理数据)中的应用。The present invention also provides the use of the above-mentioned device in processing, managing or analyzing perioperative physiological parameters or physiological data, such as perioperative physiological parameters or physiological data.
本发明还提供上述装置在处理、管理或分析围手术期生理参数或生理数据(例如围手术期生理参数或生理数据)的***中的应用。The present invention also provides the application of the above-mentioned device in a system for processing, managing or analyzing perioperative physiological parameters or physiological data (eg, perioperative physiological parameters or physiological data).
本发明还提供上述装置或方法在抑制和/或治疗围手术期并发症中的应用。其中，所述并发症可以为与肌肉组织氧和血流动力学相关疾病(例如脑溢血、大出血、子宫切除等)治疗时产生的并发症，例如为PONV。所述装置或方法优选用于抑制和/或治疗围腹腔镜子宫切除术期PONV中的应用，例如用于降低腹腔镜子宫切除术后的24小时PONV发生率。The present invention also provides the application of the above-mentioned device or method in the prevention and/or treatment of perioperative complications. Wherein, the complications may be complications arising from the treatment of diseases related to muscle tissue oxygenation and hemodynamics (such as cerebral hemorrhage, massive bleeding, hysterectomy, etc.), such as PONV. The device or method is preferably for use in the inhibition and/or treatment of PONV during peri-laparoscopic hysterectomy, eg for reducing the incidence of 24-hour PONV after laparoscopic hysterectomy.
本发明还提供上述装置或方法在围手术期低血压诊断中的应用。The present invention also provides the application of the above device or method in the diagnosis of perioperative hypotension.
本发明还提供上述装置或方法在促进术后恢复中的应用。The present invention also provides the application of the above device or method in promoting postoperative recovery.
本发明中，所述围手术期包括手术前、手术中和手术后的管理期。In the present invention, the perioperative period includes the management periods before, during and after surgery.
本发明对围手术期管理对象的肌肉组织氧和血流动力学体征数据进行监测管理，通过比较管理对象在术中肌肉组织氧和血流动力学体征参数监测值与其术前基线值之间的关系，能够对术中产生的各种情况进行合理干涉，以减少管理对象术后并发症的发生率，降低管理对象的住院期。The present invention monitors and manages the muscle tissue oxygen and hemodynamic sign data of the perioperative management object, and compares the monitoring value of the muscle tissue oxygen and hemodynamic sign parameters of the managed object during the operation with the preoperative baseline value. It can reasonably intervene in various situations that arise during the operation, so as to reduce the incidence of postoperative complications of the managed objects and reduce the hospitalization period of the managed objects.
发明人发现，胃肠道灌注不足可能是造成PONV的潜在原因之一，但现有技术无法直接监测患者的胃肠组织灌注，也无法满足胃肠组织代谢需求的充分性。而骨骼肌的表面位置允许用非侵入性探针探寻其组织灌注情况，且就器官血液流量的压力自动调节而言，内脏器官的调节机制似乎更接近于骨骼肌，而不是像大脑这种的非内脏重要器官。因此本发明出人预料地以骨骼肌作为一种潜在的监测胃肠组织的替代物，并优选使用自带判断功能的管理装置无创地在床旁测量肌肉组织氧饱和度(SmtO
2，其本质上是对肌肉组织中氧气供应与消耗速率之间平衡的一种度量)，以及对血压和心排量进行连续监测，意外地发现：
The inventors have found that hypoperfusion of the gastrointestinal tract may be one of the potential causes of PONV, but the existing technology cannot directly monitor the perfusion of the gastrointestinal tissue in patients, nor can it meet the adequacy of the metabolic needs of the gastrointestinal tissue. While the superficial location of skeletal muscle allows noninvasive probing of tissue perfusion, and in terms of pressure autoregulation of organ blood flow, the regulation mechanism of internal organs seems to be closer to that of skeletal muscle than that of the brain. non-visceral vital organs. Therefore, the present invention unexpectedly uses skeletal muscle as a potential substitute for monitoring gastrointestinal tissue, and preferably uses a management device with its own judgment function to non-invasively measure muscle tissue oxygen saturation (SmtO 2 , its essence above is a measure of the balance between oxygen supply and rate of consumption in muscle tissue), along with continuous monitoring of blood pressure and cardiac output, unexpectedly found that:
(1)肌肉SmtO
2指导的术中管理可有效治疗SmtO
2降低，一定程度上可以降低腹腔镜子宫切除术后的24小时PONV发生率；
(1) The intraoperative management guided by muscle SmtO 2 can effectively treat the decrease of SmtO 2 , and to some extent, it can reduce the incidence of 24-hour PONV after laparoscopic hysterectomy;
(2)在体重指数≥25的患者中，肌肉SmtO
2指导管理可显著降低腹腔镜子宫切除术后的24小时PONV发生率，PONV发生率从常规管理组的41.3％降至SmtO
2指导管理组的24.0％。
(2) In patients with body mass index ≥ 25, muscle SmtO2 - guided management can significantly reduce the incidence of 24-hour PONV after laparoscopic hysterectomy, and the incidence of PONV decreased from 41.3% in the routine management group to the SmtO2 - guided management group 24.0%.
发明人认为，上述结果说明以目标为导向的个性化SmtO
2指导的管理可通过优化组织灌注进一步改善临床效果。
The inventors believe that the above results illustrate that goal-oriented, individualized SmtO 2 -guided management can further improve clinical outcomes by optimizing tissue perfusion.
图1为实施例中SmtO
2监测指导的干预管理方案流程图。
Fig. 1 is a flow chart of the intervention management program guided by SmtO2 monitoring in the embodiment.
图2为实施例基于低于目标的SmtO
2AUC的治疗功效。
Figure 2 is the therapeutic efficacy of the Examples based on SmtO2 AUC below target.
图3为实施例预先指定的亚组中PONV的风险比BMI≥25的患者的24小时PONV率在组间的差异性对比。Fig. 3 is a comparison of the differences in the 24-hour PONV rate among the groups of patients whose PONV risk ratio BMI≥25 in the pre-specified subgroup of the example.
图4为实施例1围手术期管理装置的结构示意图。FIG. 4 is a schematic structural diagram of the perioperative management device in Embodiment 1. FIG.
下文将结合具体实施例对本发明的技术方案做更进一步的详细说明。应当理解，下列实施例仅为示例性地说明和解释本发明，而不应被解释为对本发明保护范围的限制。凡基于本发明上述内容所实现的技术均涵盖在本发明旨在保护的范围内。The technical solutions of the present invention will be further described in detail below in conjunction with specific embodiments. It should be understood that the following examples are only for illustrating and explaining the present invention, and should not be construed as limiting the protection scope of the present invention. All technologies realized based on the above contents of the present invention are covered within the scope of protection intended by the present invention.
除非另有说明，以下实施例中使用的元件、检测或监测装置为市售商品，或者可以通过已知方法制备。Unless otherwise stated, the elements, detection or monitoring devices used in the following examples are commercially available or can be prepared by known methods.
实施例1Example 1
如图4所示的一种围手术期管理装置，包括：信号采集模块1、数据处理模块2和显示模块3；A perioperative management device as shown in Figure 4, comprising: a signal acquisition module 1, a data processing module 2 and a display module 3;
信号采集模块1用于采集管理对象的体征信号：肌肉组织氧信号和血流动力学体征信号；The signal collection module 1 is used to collect the sign signals of the managed objects: muscle tissue oxygen signals and hemodynamic sign signals;
数据处理模块2与信号采集模块1连接，其用于接收与处理管理对象的体征信号，以使其转化为体征参数，得到肌肉组织氧参数和血流动力学参数。The data processing module 2 is connected with the signal acquisition module 1, and is used for receiving and processing the sign signal of the managed object, so as to convert it into sign parameters, and obtain muscle tissue oxygen parameters and hemodynamic parameters.
数据处理模块2能够存储或可被输入参比参数，用于将体征参数中的一种或多种与其参比参数进行比较。即通过数据处理模块来分析肌肉组织氧参数、血流动力学参数与各参数基线值或者目标曲线下面积之间的关系。通过数据处理模块的分析结果，判断是否进入管理模式或进入下一参数判断模式。The data processing module 2 can store or can be input with reference parameters for comparing one or more of the sign parameters with their reference parameters. That is, the data processing module is used to analyze the relationship between the muscle tissue oxygen parameter, the hemodynamic parameter and the baseline value of each parameter or the area under the target curve. Through the analysis result of the data processing module, it is judged whether to enter the management mode or enter the next parameter judgment mode.
显示模块3与数据处理模块2连接，用于显示数据处理模块输出的可视化数据。The display module 3 is connected with the data processing module 2, and is used for displaying the visualized data output by the data processing module.
其中，肌肉组织氧(SmtO
2)选自侧腹SmtO
2和前臂SmtO
2。
Wherein, muscle tissue oxygen (SmtO 2 ) is selected from flank SmtO 2 and forearm SmtO 2 .
血流动力学体征重点关注心排量(CO)和血压(BP)。其中，心排量的决定因素包括每搏率(SV)和心率(HR)。血压的决定因素包括心排量和***性血管阻力(SVR)。Hemodynamic signs focus on cardiac output (CO) and blood pressure (BP). Among them, the determinants of cardiac output include stroke rate (SV) and heart rate (HR). Determinants of blood pressure include cardiac output and systemic vascular resistance (SVR).
信号采集模块1包括：信号采集器11，用于采集对象的体征信号。信号采集器包括直接采集体征信号的传感器。The signal collection module 1 includes: a signal collector 11, configured to collect the sign signal of the subject. The signal collector includes sensors that directly collect the sign signal.
信号采集器11包括用于第一信号采集器111、第二信号采集器112、第三信号采集器113、第四信号采集器114和第五信号采集器115；第一信号采集器111用于采集侧腹SmtO
2，第二信号采集器112用于采集前臂SmtO
2，第三信号采集器113用于采集血压信号，第四信号采集器114用于采集每搏率(SV)，第五信号采集器115用于采集心率(HR)。
The signal collector 11 includes a first signal collector 111, a second signal collector 112, a third signal collector 113, a fourth signal collector 114 and a fifth signal collector 115; the first signal collector 111 is used for Collect flank SmtO 2 , the second signal collector 112 is used to collect forearm SmtO 2 , the third signal collector 113 is used to collect blood pressure signals, the fourth signal collector 114 is used to collect stroke rate (SV), and the fifth signal The collector 115 is used to collect heart rate (HR).
数据处理模块2包括信号处理器，用于接收与处理信号采集器中传感器采集的信号。The data processing module 2 includes a signal processor for receiving and processing the signals collected by the sensors in the signal collector.
具体地，数据处理模块2包括肌肉组织氧数据处理模块21和与肌肉组织氧数据处理模块连接的血流动力学参数数据处理模块22。Specifically, the data processing module 2 includes a muscle tissue oxygen data processing module 21 and a hemodynamic parameter data processing module 22 connected to the muscle tissue oxygen data processing module.
信号处理器包括第一信号处理器211和第二信号处理器221，第一信号处理器设置在肌肉组织氧数据处理模块中，第二信号处理器设置在血流动力学参数数据处理模块。其中，第一信号处理器用于将管理对象的肌肉组织氧信号转化为对应的参数，第二信号处理器用于将管理对象的血流动力学参数信号转化为对应的参数。The signal processor includes a first signal processor 211 and a second signal processor 221, the first signal processor is set in the muscle tissue oxygen data processing module, and the second signal processor is set in the hemodynamic parameter data processing module. Wherein, the first signal processor is used to convert the muscle tissue oxygen signal of the managed subject into corresponding parameters, and the second signal processor is used to convert the hemodynamic parameter signal of the managed subject into corresponding parameters.
肌肉组织氧数据处理模块21包括并列的侧腹SmtO
2数据处理模块和前臂SmtO
2数据处理模块；当至少一个数据处理模块中的SmtO
2监测值<70％或低于其基线值(优选以二者数值中的较高者为准)，并持续时间≥60s时，则开始进入血流动力学参数数据处理模块；若否，则保持继续监测状态。
Muscle tissue oxygen data processing module 21 comprises side abdomen SmtO 2 data processing modules and forearm SmtO 2 data processing modules juxtaposed; when the SmtO in at least one data processing module monitoring value<70% or lower than its baseline value (preferably in two whichever is higher), and the duration is ≥ 60s, then start to enter the hemodynamic parameter data processing module; if not, keep the continuous monitoring state.
血流动力学参数数据处理模块22包括顺次连接的心排量数据处理模块、***性血管阻力数据处理模块和血压数据处理模块。当监测值与该参数的预设数值之间的关系判断为“否”时，则提示进入下一参数判断模式；当为“是”时，则提示进入管理模式。其中的“否”分为达到预设数值和未达到预设数值两种情况，主要取决于待判断的体征参数。The hemodynamic parameter data processing module 22 includes a sequentially connected cardiac output data processing module, a systemic vascular resistance data processing module and a blood pressure data processing module. When the relationship between the monitoring value and the preset value of the parameter is judged as "No", it prompts to enter the next parameter judgment mode; when it is "Yes", it prompts to enter the management mode. "No" can be divided into two situations: reaching the preset value and not reaching the preset value, which mainly depends on the sign parameters to be judged.
心排量数据处理模块包括并列且互连的心率数据处理模块和每搏率数据处理模块。其中，每搏率数据处理模块包括并列的前负荷数据处理模块、后负荷数据处理模块和收缩力数据处理模块，前负荷数据处理模块和后负荷数据处理模块分别与收缩力数据处理模块连接。The cardiac output data processing module includes a parallel and interconnected heart rate data processing module and a beat rate data processing module. Wherein, the beat rate data processing module includes parallel preload data processing module, afterload data processing module and contraction force data processing module, and the preload data processing module and afterload data processing module are respectively connected with the contraction force data processing module.
其中，当心排量数据处理模块的监测值达到该参数的基线值时，则提示查看每搏率数据处理模块。当心排量数据处理模块的监测值未达到该参数的基线值时，则提示进入前负荷数据处理模块或后负荷数据处理模块。进一步地，当前负荷数据处理模块或后负荷数据处理模块的监测值、未达到该参数的基线值或者标量差值时，则提示进入收缩力数据模块；当达到该参数的基线值或者标量差值时，则提示进入管理模式。Wherein, when the monitoring value of the cardiac output data processing module reaches the baseline value of the parameter, it prompts to check the stroke rate data processing module. When the monitoring value of the cardiac output data processing module does not reach the baseline value of the parameter, it prompts to enter the preload data processing module or the afterload data processing module. Further, when the monitoring value of the current load data processing module or the afterload data processing module does not reach the baseline value or scalar difference of the parameter, it prompts to enter the contraction force data module; when the baseline value or scalar difference of the parameter is reached , prompts to enter management mode.
当各个血流动力学参数数据处理模块均完成判断，而判断依旧为“否”时，则提示观察肌肉组织氧数据处理模块。When each hemodynamic parameter data processing module completes the judgment, and the judgment is still "No", it prompts to observe the muscle tissue oxygen data processing module.
上述各模块之间的连接为有线连接或无线连接。The connection between the above modules is a wired connection or a wireless connection.
显示模块3包括提供显示界面的触摸式显示屏8以及显示控制器7，显示控制器7用于将控制输出的可视化图形、文字、图片等的显示和/或更新。The display module 3 includes a touch screen 8 providing a display interface and a display controller 7, the display controller 7 is used to display and/or update control output visual graphics, text, pictures, etc.
管理装置包括：中央处理器4，作为数据处理及各模块的最终处理、执行单元；The management device includes: a central processing unit 4, which is used as the final processing and execution unit for data processing and each module;
一个或多个存储器5，上述各模块可分别置于不同的存储器中；由中央处理器运行或执行存储在存储器中的各个模块，以执行装置的各种功能和处理数据；One or more memory 5, the above-mentioned modules can be respectively placed in different memories; each module stored in the memory is operated or executed by the central processing unit to perform various functions of the device and process data;
通讯模块9，用于接受通讯信号并将其转化为电信号，以及将电信号转化为通讯信号后发送；选用本领域已知组件模块，使用通信标准、协议等中的任意一种尽心有线或无线通讯；管理装置能够通过通讯模块与外部网络或其他设备进行通讯连接；The communication module 9 is used to receive the communication signal and convert it into an electrical signal, and convert the electrical signal into a communication signal before sending it; select component modules known in the art, and use any communication standard, protocol, etc. Wireless communication; the management device can communicate with external networks or other devices through the communication module;
电源***10，为管理装置中的各模块、元件或电路提供电力；The power supply system 10 provides power for each module, component or circuit in the management device;
外设接口6，与中央处理器、信号采集器、通讯模块、显示控制器分别连接。The peripheral interface 6 is respectively connected with the central processing unit, the signal collector, the communication module and the display controller.
实施例2Example 2
1.实验介绍1. Experiment introduction
多中心、实用、患者和评估盲法随机对照(1:1比例)试验，从2018年9月至2019年6月在6家教学医院进行。随机分配年龄在18-65岁之间，不吸烟且接受子宫切除术的选择性腹腔镜手术的女性患者(n＝800)中SmtO
2指导的管理或常规管理。目标是保持SmtO
2≥基线或70％目标曲线下面积AUC，以较高者为准。治疗效果通过低于目标曲线下面积(AUC)来评估。
Multicentre, pragmatic, patient- and assessment-blinded randomized controlled (1:1 ratio) trial conducted at six teaching hospitals from September 2018 to June 2019. SmtO2 - guided management or usual management in nonsmoking female patients (n = 800) aged 18-65 years who underwent elective laparoscopic surgery for hysterectomy were randomly assigned. The goal is to maintain SmtO2 ≥ baseline or 70% of target area under the curve AUC, whichever is higher. The treatment effect was assessed by the area under the curve (AUC) below the target.
2.实验过程2. Experimental process
2.1管理对象2.1 Management object
管理对象满足以下条件：Managed objects meet the following conditions:
1)年龄18-65岁；1) Age 18-65;
2)不吸烟者；2) Non-smokers;
3)身体状况属于美国麻醉医师协会(ASA)规定的身体状况I-III级；3) The physical condition belongs to the physical condition class I-III stipulated by the American Society of Anesthesiologists (ASA);
4)包括子宫切除术在内的选择性腹腔镜手术。4) Elective laparoscopic surgery including hysterectomy.
排除标准：Exclusion criteria:
1)患者拒绝参加的；1) The patient refuses to participate;
2)紧急手术；2) emergency surgery;
3)计划进行肠切除；3) Intestinal resection is planned;
4)***或腹部(开放式)子宫切除术；4) Vaginal or abdominal (open) hysterectomy;
5)手术前3个月内进行化学疗法或放射疗法；5) Chemotherapy or radiotherapy within 3 months before surgery;
6)严重的神经，认知或心理疾病：中风伴神经功能缺损，痴呆，精神***症或任何不可能进行有意义的术后随访的疾病；6) Severe neurological, cognitive or psychological diseases: stroke with neurological deficits, dementia, schizophrenia or any disease that is unlikely to have meaningful postoperative follow-up;
7)严重的心血管疾病：低输出性心力衰竭(定义为术前左心室射血分数<30％)，活动性冠状动脉疾病，有症状的瓣膜病或有或没有起搏器和/或自动植入式心脏复律除颤器(AICD)的症状性心律不齐；7) Severe cardiovascular disease: low output heart failure (defined as preoperative left ventricular ejection fraction <30%), active coronary artery disease, symptomatic valvular disease with or without pacemaker and/or automatic Symptomatic arrhythmias in implantable cardioverter-defibrillators (AICDs);
8)严重的肺部疾病：需要家庭供氧疗法的慢性阻塞性肺病(COPD)，需要类固醇治疗的严重哮喘或其他需要家庭供氧疗法的肺部疾病；8) Severe lung disease: chronic obstructive pulmonary disease (COPD) requiring home oxygen therapy, severe asthma requiring steroid therapy, or other lung disease requiring home oxygen therapy;
9)严重肝功能不全正在接受肝移植或Child-Pugh C级评估；9) Severe hepatic insufficiency is undergoing liver transplantation or Child-Pugh C assessment;
10)严重肾功能不全，需要肾脏替代治疗；10) Severe renal insufficiency requiring renal replacement therapy;
11)肌肉疾病，如营养不良，萎缩和虚弱；11) Muscle diseases such as malnutrition, atrophy and weakness;
12)与粘性血氧饱和度探针不兼容的皮肤状况(例如，脆弱或有纹身的皮肤)；12) Skin conditions incompatible with adhesive oximetry probes (e.g., fragile or tattooed skin);
13)现在或以前的吸烟者；13) Current or former smokers;
14)ASA身体状况>III。14) ASA physical status > III.
2.2分组2.2 Grouping
符合上述条件的管理对象将被随机分配到以下两组之一：Administered subjects meeting the above criteria will be randomly assigned to one of the following two groups:
·干预组：患者在手术期间除常规管理外还接受SmtO
2指导的管理。
Intervention group: Patients received SmtO 2 -guided management during surgery in addition to routine management.
·对照组：患者在手术期间仅接受常规管理。Control group: patients only received routine management during the operation.
2.3术前准备2.3 Preoperative preparation
使用统计软件包(9.3版，SAS Institute Inc.，Cary，NC)，根据受试者分组随机分组(每组人数 为4)，手术前30-60分钟以1:1的比例将参与者随机分配到SmtO
2指导的管理组或常规管理组中。
Using a statistical software package (version 9.3, SAS Institute Inc., Cary, NC), according to subject group randomization (4 people per group), participants were randomly assigned in a 1:1 ratio 30-60 minutes before surgery To SmtO 2 directed management group or regular management group.
使用实施例1提供的管理装置对两个治疗组的患者进行监测。Patients in the two treatment groups were monitored using the management device provided in Example 1.
在SmtO
2指导的管理组中按照SmtO
2指导的2.2节提供的管理方案对患者进行管理，而在常规管理组中，装置的屏幕均覆盖有不透明的布，患者接受医院的常规管理。
In the SmtO 2 -guided management group, patients were managed according to the management scheme provided in Section 2.2 of the SmtO 2 -guidance, while in the routine management group, the screens of the devices were covered with opaque cloth, and the patients received the routine management of the hospital.
2.4肌肉SmtO
2和血流动力学监测
2.4 Muscle SmtO 2 and hemodynamic monitoring
1)将使用实施例1装置对两组患者进行监测。1) Two groups of patients will be monitored using the device of Example 1.
2)在患者到达前15-30分钟在手术室分发，连接和激活实施例1装置。2) The device of Example 1 is distributed, connected and activated in the operating room 15-30 minutes before the arrival of the patient.
3)将使用实施例1装置在两个不同的位置监视组织氧合作用。数据将由麻醉师(用于干预组)用于术中管理，并进行收集。3) The device of Example 1 will be used to monitor tissue oxygenation at two different locations. Data will be collected by the anesthetist (for the intervention group) for intraoperative management.
分析(针对两组-SmtO
2指导干预管理组和常规管理组)：
Analysis (for two groups - SmtO 2 guided intervention management group and usual management group):
a将装置与管理对象的左侧大部分脊柱旁肌肉的顶部，垂直于L2-3的脊柱处连接，以监测侧腹SmtO
2。
a Attach the device to the top of the subject's left most paraspinal muscles, perpendicular to the spine at L2-3, to monitor flank SmtO2 .
b将装置与管理对象的左臂大臂肱肌的顶部，大约在肘前折痕下方(前臂的side侧)下方两根手指处连接，以监测臂SmtO
2。为了实现标准化，首选使用左臂，这也是用于考察血流动力学参数的手臂。将用于无创血压监测的袖带(常规管理的一部分)放在右臂上。
b Attach the device to the top of the brachialis brachialis muscle of the subject's left arm, approximately two fingers below the antecubital crease (side of the forearm) to monitor arm SmtO2 . For standardization, the left arm is preferred, which is also the arm used to investigate hemodynamic parameters. A cuff for non-invasive blood pressure monitoring (part of routine management) was placed on the right arm.
4)将装置中测量血流动力学参数的部件放置在左臂上。4) Place the part of the device for measuring hemodynamic parameters on the left arm.
5)监测和数据记录将在麻醉诱导前约5-10分钟(患者清醒，平静和呼吸室内的空气)开始，并在手术结束时即在患者离开手术台前立即停止去盖尼式床。氧合和血液动力学数据将由计算机同时捕获。5) Monitoring and data recording will begin approximately 5-10 minutes before induction of anesthesia (patient is awake, calm and breathing room air) and will stop at the end of the procedure, immediately before the patient leaves the operating table to go to the gurney. Oxygenation and hemodynamic data will be simultaneously captured by computer.
2.5腹腔镜子宫切除术中SmtO
2指导的处理
2.5 SmtO2 - guided management during laparoscopic hysterectomy
如图1所示流程：The flow shown in Figure 1:
1)两组的基线测量值：麻醉诱导前以及患者平静和呼吸的空气中，基线侧腹SmtO
2，前臂SmtO
2，BP(血压)，CI(心脏指数)，每搏率(SV)，心率(HR)和全身血管阻力(SVR)将被测量并记录为基线值。必须进行判断以确保记录的测量结果可靠。例如，如有必要，将重复进行BP测量，直到获得可靠的数值为止。可靠性的判断必须考虑患者的年龄，以前的测量以及医疗和身体状况。轻度镇静时，如10-20mg异丙酚或1-4mg咪达***，可在需要使患者平静并获得正确的基线值时用于轻度镇静。
1) Baseline measurements in both groups: before induction of anesthesia and in the patient's calm and breathing air, baseline flank SmtO 2 , forearm SmtO 2 , BP (blood pressure), CI (cardiac index), stroke rate (SV), heart rate (HR) and systemic vascular resistance (SVR) will be measured and recorded as baseline values. Judgment must be exercised to ensure that the recorded measurements are reliable. For example, BP measurements will be repeated if necessary until reliable values are obtained. Judgments of reliability must take into account the patient's age, previous measurements, and medical and physical condition. Mild sedation, such as 10-20 mg propofol or 1-4 mg midazolam, can be used for light sedation when needed to calm the patient and obtain correct baseline values.
2)对照组：管理装置的屏幕将被覆盖，以使麻醉医师无法读取它们。2) Control group: The screens of the management device will be covered so that they cannot be read by the anesthesiologist.
3)干预组：麻醉医师将使用管理装置监测进行术中管理。以下4)-8)的描述仅适用于该组。3) Intervention group: anesthesiologists will use the management device to monitor and perform intraoperative management. The descriptions of 4)-8) below apply only to this group.
4)SmtO
2目标：侧面和前臂的测量值都将用于干预指导，目标是在手术过程中除了常规管理外，还要保持侧面和前臂SmtO
2≥70％或≥基线，以较高者为准。
4) SmtO2 goal: Both lateral and forearm measurements will be used to guide intervention, with the goal to maintain lateral and forearm SmtO2 ≥70% or ≥ baseline, whichever is higher, during surgery in addition to routine management allow.
5)干预时机：如果SmtO
2≥70％和≥基线，则不得根据研究方案进行干预。仅当SmtO
2低于目标时才应开始干预。该指令适用于侧面SmtO
2和前臂SmtO
2。
5) Timing of intervention: If SmtO 2 ≥70% and ≥baseline, no intervention shall be performed according to the research protocol. Intervention should only be initiated when SmtO2 is below target. This instruction applies to lateral SmtO 2 and forearm SmtO 2 .
6)干预算法(当侧面或手臂SmtO
2低于目标时)
6) Intervention algorithm (when side or arm SmtO 2 is below target)
§第一步是在SmtO
2低于目标时检查CO。
§ The first step is to check CO when SmtO2 is below target.
§如果CO小于基线，请检查SV和HR以了解CO减少的原因。§ If CO is less than baseline, check SV and HR for reason for CO decrease.
§如果SV下降是可能的原因，请检查SV变化(SVV)和△SV(△SV＝在后SV监测值-在先SV监测值)，以确定患者是否可以从中受益。通过在2-3分钟内给患者250毫升乳酸林格氏液(LR)评估△SV，以确定在推注之前和之后SV的差异。如果SVV>12％或△SV≥10％，即患者可能对液体敏感，则可以进行液体推注(250ml LR)并再次检查。重复直到SVV<12％或△SV<10％。这些百分比仅是参考值。即使SVV<12％或△SV<10％，也可以改善SmtO
2的情况下进行静脉推注。如果在1500-2000 ml LR溶液后SmtO
2没有改善，则需要停止并咨询高级麻醉师以获取建议。
§If a decreased SV is the likely cause, check the SV change (SVV) and ΔSV (ΔSV = subsequent SV monitoring value - prior SV monitoring value) to determine if the patient could benefit from it. The ΔSV was assessed by giving the patient 250 mL of Lactated Ringer (LR) over 2-3 minutes to determine the difference in SV before and after the bolus injection. If SVV>12% or △SV≥10%, that is, the patient may be sensitive to fluid, a fluid bolus (250ml LR) can be performed and rechecked. Repeat until SVV<12% or ΔSV<10%. These percentages are indicative values only. Even if SVV < 12% or ΔSV < 10%, intravenous bolus injection can be performed in the case of improved SmtO 2 . If SmtO2 does not improve after 1500-2000 ml of LR solution, it needs to be stopped and consult a senior anesthetist for advice.
如果能够确定SV降低极有可能的因素，但患者对液体推注无反应，则考虑潜在的心肌抑制作用(即收缩力降低)。但原则上尽可能避免使用潜在的心肌抑制剂，可以考虑以增加去甲肾上腺素的输注或增加心肌收缩力的替代。If a highly probable factor for the decreased SV can be identified but the patient is unresponsive to the fluid bolus, consider potential myocardial depression (ie, decreased contractility). However, in principle, avoid the use of potential myocardial inhibitors as much as possible, and consider increasing the infusion of norepinephrine or increasing myocardial contractility instead.
§如果可能导致HR降低，则考虑小剂量的阿托品(静脉推注0.1-0.2mg)，并在必要时重复。如果同时血压低，则可以使用麻黄碱(5-10毫克)作为替代品。广泛接受的HR范围是50-100bpm。但是，允许在此范围内微调HR。如果心率超出此范围，则需要咨询高级麻醉师以获取建议。整个过程中始终将基线作为参考。因此，必须在患者保持镇静和休息的情况下获得可靠的基线HR。如果感到焦虑，患者的心律可能会加快。§Consider low-dose atropine (0.1-0.2 mg IV bolus) if HR reduction is likely and repeat if necessary. If blood pressure is low at the same time, ephedrine (5-10 mg) can be used as a substitute. A widely accepted HR range is 50-100bpm. However, fine-tuning of HR within this range is allowed. If the heart rate is outside this range, a senior anesthesiologist will need to be consulted for advice. Always use the baseline as a reference throughout the process. Therefore, a reliable baseline HR must be obtained with the patient sedated and rested. If anxious, the patient's heart rate may increase.
§如果SVR高于基线的80％，则考虑尼卡地平输注以使小动脉血管舒张。§If SVR is above 80% of baseline, consider nicardipine infusion to vasodilate arterioles.
§如果BP低但CO高于基线，则应考虑使用临床上合适的输注速率或推注剂量的去氧肾上腺素输注或麻黄碱推注。BP＝CO×SVR。§If BP is low but CO is above baseline, consider using a clinically appropriate infusion rate or bolus dose of phenylephrine infusion or ephedrine bolus. BP = CO x SVR.
如果CO稳定，则BP降低的原因是SVR降低。指示的干预措施是血管加压药。有证据表明去氧肾上腺素推注可减少一氧化碳。目标BP范围为基线的80％以上。但是，当情况有所不同时，则需要麻醉师能够始终进行正确的临床判断。因此，必须在患者保持冷静和休息的情况下采取可靠的基线BP。如果患者感到焦虑，血压可能会比静息值高得多。If CO is stable, the reason for the decrease in BP is the decrease in SVR. The indicated intervention is vasopressors. There is evidence that phenylephrine boluses reduce carbon monoxide. The target BP range is above 80% of baseline. However, when the situation is different, the anesthetist needs to be able to always exercise sound clinical judgment. Therefore, a reliable baseline BP must be taken with the patient calm and rested. If the patient is anxious, blood pressure may be much higher than the resting value.
建议在BP之前治疗CO。如果CO干预后BP改善，则不再需要治疗BP。只需重复上述步骤即可。It is recommended to treat CO before BP. If BP improves after CO intervention, BP treatment is no longer necessary. Just repeat the steps above.
§如果认为血流动力学可接受，但SmtO
2仍低于目标，则按照图1所示的干预流程图下移以评估其他方面。
§ If hemodynamics are deemed acceptable but SmtO2 remains below target, move down the intervention algorithm shown in Figure 1 to assess other aspects.
§确保没有动脉饱和或急性出血。根据患者的身体和医疗状况，保持SpO
2>95％，血红蛋白>7-9g/dl。如果在临床决策中使用血红蛋白浓度，则务必考虑血管内容量状态，因为血容量过低(血药浓度)会导致虚高的血红蛋白水平。仅在纠正血容量不足后才显示血红蛋白水平低。
§ Ensure there is no arterial saturation or acute bleeding. Depending on the patient's physical and medical condition, maintain SpO 2 >95% and hemoglobin >7-9 g/dl. If hemoglobin concentration is used in clinical decision-making, it is important to consider intravascular volume status because hypovolemia (blood drug levels) can lead to artificially high hemoglobin levels. Low hemoglobin levels appear only after hypovolemia is corrected.
避免不必要的过度换气，因为它可能导致血管收缩和组织灌注不足。维持正常状态(EtCO
2＝30-40mmHg)。
Avoid unnecessary hyperventilation as it may lead to vasoconstriction and tissue hypoperfusion. Maintain normal conditions (EtCO 2 =30-40mmHg).
§始终将核心温度保持在正常范围(36-37℃)。§Keep core temperature within the normal range (36-37°C) at all times.
§如果肌肉运动，请检查肌肉抽搐并以临床上适当的方式使用肌肉松弛剂。活动会增加肌肉耗氧量，从而导致SmtO
2降低。
§ If muscle movement, check for muscle twitching and administer muscle relaxants in a clinically appropriate manner. Activity increases muscle oxygen consumption, which leads to a decrease in SmtO2 .
§如果认为腹内压力过高，请考虑将吹入压力降低2-3使其≤10cmH
2O。
§If the intra-abdominal pressure is considered too high, consider reducing the insufflation pressure by 2-3 to ≤10 cmH 2 O.
§始终确保所监测的肌肉没有受到压迫。始终确保正确使用探头和袖带。§Always ensure that the monitored muscle is not compressed. Always ensure proper probe and cuff use.
§请记住，在采取上述干预措施后，并非总是可能将SmtO
2维持在目标范围内。
§ Keep in mind that it is not always possible to maintain SmtO2 within the target range following the above interventions.
7)在试验过程中，麻醉师应及时将基于SmtO
2监测的每种干预措施记录在CRF上。
7) During the trial, the anesthetist should promptly record each intervention based on SmtO2 monitoring on the CRF.
8)如果患者安全受到威胁，则可以忽略上述任何干预步骤。8) If patient safety is at stake, any of the above intervention steps can be ignored.
上述所做的任何事情都不应被视为偏离标准管理(DO NO HARM)。Nothing done above should be considered DO NO HARM.
2.7干预组和对照组的围手术期管理2.7 Perioperative management of intervention group and control group
围手术期的管理将符合调查现场当前的管理标准。Perioperative management will be in line with current management standards at the investigation site.
2.7.1术前2.7.1 Preoperative
(1)NPO指南和肠道准备(1) NPO guidelines and bowel preparation
手术当日午夜后无固体食物No solid food after midnight on the day of surgery
§引诱前2个小时内可以接受透明液体，除非患有严重的胃食管反流病(GERD)或症状性胃轻瘫的患者§ Clear fluids may be received within 2 hours of induction, except in patients with severe gastroesophageal reflux disease (GERD) or symptomatic gastroparesis
§肠道准备符合医院的管理标准§Bowel preparation complies with hospital management standards
(2)避免：不必要的苯二氮卓类药物和阿片类药物(2) Avoid: Unnecessary Benzodiazepines and Opioids
2.7.2术中2.7.2 Intraoperative
(1)止吐药(1) Antiemetics
§***4-5毫克IV；§ Dexamethasone 4-5 mg IV;
§恩丹西酮4毫克IV。§ Ondansetron 4 mg IV.
(2)TIVA(全静脉内麻醉)用于维持麻醉(2) TIVA (Total Intravenous Anesthesia) for maintenance of anesthesia
§异丙酚输注，50-200mcg/kg/min，滴定至有效；§Propofol infusion, 50-200mcg/kg/min, titrated to effective;
§瑞芬太尼输注，0.05-0.2mcg/kg/分钟，滴定生效。§Remifentanil infusion, 0.05-0.2mcg/kg/min, titrated to effect.
(3)止痛药(3) Painkillers
§舒芬太尼静脉推注，剂量基于临床判断；§ Sufentanil is intravenously injected, and the dose is based on clinical judgment;
§外科医生进行局部麻醉伤口注射。§ Surgeon administers local anesthesia wound injection.
(4)维持正常体温(4) Maintain normal body temperature
§使用主动加热装置；§ Use active heating devices;
§如果使用大量静脉输液，应加温水。§If using large volumes of IV fluids, add warm water.
(5)液体疗法(5) Fluid therapy
§LR以减少盐分负荷。§LR to reduce salt load.
2.7.3术后：2.7.3 After surgery:
疼痛管理pain management
§根据医院止吐的管理标准；§According to the hospital's antiemetic management standards;
§根据医院的管理标准。§According to the management standard of the hospital.
2.8收集数据2.8 Collect data
2.8.1术前资料2.8.1 Preoperative data
1)基于纳入和排除标准的患者资格；1) Patient eligibility based on inclusion and exclusion criteria;
2)人口统计数据，基线特征，既往医疗和手术史；2) Demographic data, baseline characteristics, previous medical and surgical history;
3)实验室检查结果包括血红蛋白，血细胞比容和肌酐。3) Laboratory test results include hemoglobin, hematocrit and creatinine.
2.8.2术中数据2.8.2 Intraoperative data
1)手术细节，包括手术类型和持续时间；1) Surgical details, including type and duration of surgery;
2)麻醉细节，包括手术期间使用的任何药物的名称和剂量；2) details of anesthesia, including the name and dosage of any medications used during the procedure;
3)输入和输出，包括所用液体的名称和量，估计失血量，尿量以及所用任何血液制品；3) Inputs and outputs, including the names and volumes of fluids used, estimated blood loss, urine output, and any blood products used;
4)SmtO
2数据，包括基线测量和整个手术期间的所有数据；
4) SmtO 2 data, including baseline measurements and all data during the entire surgical period;
5)整个手术过程中LiDCO监护仪的血流动力学数据。5) The hemodynamic data of the LiDCO monitor during the whole operation.
3.考察结果3. Inspection results
主要结果：24小时PONV率，即24小时PONV的定义是手术后24小时内出现恶心，呕吐或呕吐。Main results: 24-h PONV rate, 24-h PONV was defined as nausea, vomiting or vomiting within 24 h after surgery.
次要结果：PONV的发生率以及很早(0-2小时)的恶心和疼痛的严重程度，术后早期(2-6小时)和晚期(6-24小时)。Secondary outcomes: incidence of PONV and severity of nausea and pain very early (0-2 hours), early (2-6 hours) and late (6-24 hours) postoperatively.
患者使用11级数字评分量表(NRS)，范围从0(无)到10(最差)，以评估其恶心和疼痛的严重程度。如果相应的NRS得分大于或等于5，则认为患者经历了中度至重度恶心或疼痛。Patients were assessed for the severity of their nausea and pain using an 11-point Numeric Rating Scale (NRS) ranging from 0 (none) to 10 (worst). Patients were considered to experience moderate to severe nausea or pain if the corresponding NRS score was greater than or equal to 5.
其他次要结果包括：Other secondary outcomes included:
1)手术后最初24小时的恢复质量，以15个项目的质量进行衡量-恢复量表(QoR-15)；1) Quality of recovery in the first 24 hours after surgery, measured by a 15-item quality-recovery scale (QoR-15);
2)手术后第一夜睡眠的质量；2) The quality of sleep on the first night after surgery;
3)从手术结束到第一次下床移动的时间；3) The time from the end of the operation to the first time getting out of bed;
4)从手术结束到第一次耐受餐的时间；4) The time from the end of the operation to the first tolerated meal;
5)患者住院时间长短；5) The length of the patient's hospital stay;
6)进入重症监护室；6) Entering the intensive care unit;
7)入院；7) Admission to hospital;
8)30天的死亡率和发病率。8) 30-day mortality and morbidity.
对治疗组分配不知情的独立结果评估者随访所有患者并管理所有结果数据。An independent outcome assessor blinded to treatment-group assignment followed all patients and administered all outcome data.
统计分析Statistical Analysis
假设在接受腹腔镜子宫切除术的患者中，SmtO
2指导的管理可将24小时PONV率从50％降低至40％。双面显着性和功效分别设置为0.05％和80％，检测到预期减少量所需的样本量为每组388名患者。计划每组招募400名患者，假设退出率为大约3％。基于修改后的意向治疗人群(包括所有接受过随机分组和手术的患者)进行分析。计算人口统计学，基线和围手术期特征和结果的描述性统计数据，定量变量表示为平均值(标准差)或中位数(四分位数范围，IQR)，分类变量表示为频率和百分比。围手术期特征和结局的比较使用独立的t检验或Wilcoxon秩和检验，卡方检验或Fisher精确检验进行。进行了预先指定的亚组分析和对主要结局的一系列敏感性分析。使用R(3.5.2版)软件包(包括arsenal，fmsb和sjstats)进行统计分析。P
2值小于0.05被认为对主要结局具有统计学意义。
hypothesized that in patients undergoing laparoscopic hysterectomy, SmtO2 - guided management could reduce the 24-h PONV rate from 50% to 40%. With two-sided significance and power set at 0.05% and 80%, respectively, the sample size required to detect the expected reduction was 388 patients per group. Enrollment of 400 patients in each arm is planned, assuming a dropout rate of approximately 3%. Analyzes were based on a modified intention-to-treat population that included all patients who underwent randomization and surgery. Descriptive statistics were calculated for demographic, baseline, and perioperative characteristics and outcomes, with quantitative variables expressed as mean (standard deviation) or median (interquartile range, IQR) and categorical variables expressed as frequencies and percentages . Comparisons of perioperative characteristics and outcomes were performed using independent t-tests or Wilcoxon rank-sum tests, chi-square tests, or Fisher's exact tests. Prespecified subgroup analyzes and a series of sensitivity analyzes for the primary outcome were performed. Statistical analysis was performed using the R (version 3.5.2) package including arsenal, fmsb and sjstats. A P2 value of less than 0.05 was considered statistically significant for the primary outcome.
4.结果4. Results
患者登记和特征从2018年9月至2019年6月，对计划进行子宫切除的选择性手术的1,049名患者进行了评估，随机分配了800名患者接受SmtO
2指导管理(n＝400)或常规管理(n＝400))。干预治疗组具有平衡的基线特征(表1)和平衡的基线组织氧合和血流动力学测量值(表2)。由于常规管理组中一名患者被随机分配后取消手术，因此经改良的意向治疗人群包括799名患者(SmtO
2指导管理组中为400名，常规管理组中为399名)。
Patient Enrollment and Characteristics From September 2018 to June 2019, 1,049 patients planned for elective surgery for hysterectomy were evaluated and 800 patients were randomly assigned to receive guided management of SmtO2 (n = 400) or conventional management (n=400)). The intervention treatment groups had balanced baseline characteristics (Table 1) and balanced baseline tissue oxygenation and hemodynamic measures (Table 2). Because one patient in the usual-management group was randomized and canceled surgery, the modified intention-to-treat population included 799 patients (400 in the SmtO2 - guided-management group and 399 in the usual-management group).
4.1治疗功效4.1 Therapeutic Efficacy
如图2所示，使用以下目标AUC评估了SmtO
2指导的术中管理的疗效。横坐标和纵坐标分别是手术时间和SmtO
2与预定目标之间的差。纵坐标上的零点指示SmtO
2的治疗目标，即基线或70％的AUC面积，以较高者为准。图示了来自SmtO
2指导治疗组(A)和常规管理组(B)的患者的前臂SmtO
2的连续描迹。高于目标的SmtO
2测量值以红色显示(纵坐标0点以上部分区域)，而等于或小于目标的SmtO
2测量值以蓝色显示(纵坐标0点以下部分区域)。目标下方的AUC以蓝色表示。来自SmtO
2指导管理组(C和E)和普通管理组(D和F)中患者的连续侧面(C和D)和前臂(E和F)SmtO
2描迹绘制在同一轴上，从而形成AUC来自不同患者的彼此重叠。显示了在不同位置和不同治疗组测得的中位数SmtO
2AUC。SmtO
2表示肌肉组织氧饱和度；AUC表示曲线下的面积。
As shown in Figure 2, the efficacy of SmtO2 - guided intraoperative management was assessed using the following target AUC. The abscissa and ordinate are the operation time and the difference between SmtO2 and the intended target, respectively. The zero point on the ordinate indicates the SmtO2 treatment target, i.e., baseline or 70% AUC area, whichever is higher. Sequential traces of SmtO2 forearm of patients from the SmtO2 - guided treatment group (A) and usual management group (B) are illustrated. SmtO2 measurements that are higher than the target are shown in red (the part of the area above the 0 point on the ordinate), while those that are equal to or less than the target are shown in blue (the part of the area below the 0 point on the ordinate). The AUC below the target is indicated in blue. Serial lateral (C and D) and forearm (E and F) SmtO traces from patients in the SmtO guided management group (C and E) and usual management group (D and F) are plotted on the same axis to form the AUC from different patients overlap each other. Median SmtO 2 AUC measured at different locations and different treatment groups is shown. SmtO 2 represents muscle tissue oxygen saturation; AUC represents the area under the curve.
使用曲线下方目标区域(AUC)评估了SmtO
2指导的管理将SmtO
2维持在或高于预定目标的治疗效果。较小的AUC表示较好的治疗效果，反之亦然(图2A-B)。SmtO
2指导的管理导致目标下方的SmtO
2AUC(50vs.140％.min；p<0.001；图2C-D)和前臂SmtO
2AUC(53vs.245％.min；p<0.001；P<0.001)显着减小。图2E-F)比平时管理(表2)。在SmtO
2指导的管理组中，患者的基线以下心脏指数AUC较小(71比91ml/m
2，p＝0.004)和HR AUC(849vs.1180bpm.min，p<0.001)，接受了更多的晶体(1600vs.1250ml，p<0.001)，并且比普通管理组的患者产生更多的尿液(300vs.250ml，p<0.001)。
The therapeutic effect of SmtO2 - guided management to maintain SmtO2 at or above the intended target was assessed using the target area under the curve (AUC). A smaller AUC indicates a better treatment effect and vice versa (Fig. 2A-B). SmtO 2 -guided administration resulted in SmtO 2 AUC below target (50 vs. 140%.min; p<0.001; Fig. 2C-D) and forearm SmtO 2 AUC (53vs. Significantly reduced. Figure 2E-F) than usual administration (Table 2). In the SmtO 2 -guided management group, patients had smaller cardiac index AUC (71 vs. 91ml/m 2 , p=0.004) and HR AUC (849 vs. crystals (1600vs.1250ml, p<0.001), and produced more urine (300vs.250ml, p<0.001) than patients in the usual management group.
4.1.1主要结果4.1.1 Main Results
在SmtO
2指导治疗组中，共有127例患者(31.8％)和在常规治疗组中有142例患者(35.6％)具有24小时PONV(表3)，相对于绝对风险降低了3.8％，相对风险降低了10.8％。但是，这种降低没有统计学意义(风险比为0.89[95％CI，0.73至1.08]；p＝0.25)。
A total of 127 patients (31.8%) in the SmtO 2 -guided treatment group and 142 patients (35.6%) in the usual care group had 24-hour PONV (Table 3), representing a 3.8% relative absolute risk reduction, relative risk 10.8% lower. However, this reduction was not statistically significant (hazard ratio, 0.89 [95% CI, 0.73 to 1.08]; p=0.25).
4.1.2次要结果4.1.2 Secondary results
各组在术后早期(0-2小时)，早期(2-6小时)和晚期(6-24小时)的PONV率相似(表3)。与常规管理组相比，SmtO
2指导的管理组在术后头2小时内的中度至重度恶心发生率降低了(5.0％对9.3％；风险比为0.54[95％CI，0.32至0.91]；p＝0.02)以及整个术后24小时内(15.5％vs.21.1％；风险比为0.74[95％CI，0.55至0.99]；p＝0.04)。但是，在为多个比较进行调整后，这些p值并不显着。与接受常规管理的患者相比，接受SmtO
2指导的患者在以下几个方面的康复质量有所提高：能够享受食物(p＝0.046)，感到休息(p＝0.003)，感到舒适和处于控制状态(p＝0.02)，具有一般的幸福感(p＝0.01)，并且总体感觉良好(A部分；p＝0.008；表3)。后者也报告了第一夜睡眠的质量更好(p＝0.04)(表3)。但是，在为多个比较进行调整后，这些p值并不显着。疼痛的严重程度，第一次下床活动的时间或口服喂养耐受性的恢复在两组之间没有显着差异。两组患者在手术后30天内均未死亡或有任何主要器官***并发症。
PONV rates were similar among the groups in the early postoperative period (0-2 hours), early period (2-6 hours) and late period (6-24 hours) (Table 3). Moderate to severe nausea was reduced in the first 2 hours postoperatively in the SmtO2 - guided management group compared with the usual management group (5.0% vs. 9.3%; hazard ratio, 0.54 [95% CI, 0.32 to 0.91] ; p=0.02) and throughout the 24 hours postoperatively (15.5% vs. 21.1%; hazard ratio, 0.74 [95% CI, 0.55 to 0.99]; p=0.04). However, these p-values were not significant after adjusting for multiple comparisons. Compared to patients who received usual management, patients who received SmtO2 guidance experienced improvements in the quality of recovery in terms of: being able to enjoy food (p=0.046), feeling rested (p=0.003), feeling comfortable and in control (p=0.02), generally well-being (p=0.01), and generally feeling good (Part A; p=0.008; Table 3). The latter also reported better quality of sleep on the first night (p=0.04) (Table 3). However, these p-values were not significant after adjusting for multiple comparisons. Pain severity, time to first ambulation, or recovery of oral feeding tolerance did not differ significantly between the two groups. No patient in either group died or had any major organ system complications within 30 days after surgery.
4.2小组分析4.2 Group analysis
体重指数(BMI)≥25的患者，其手术围手术期的干预和测量见表4。For patients with a body mass index (BMI) ≥ 25, the interventions and measurements during the perioperative period are shown in Table 4.
体重指数(BMI)≥25的患者，其24小时PONV率从常规管理组的41％(66/160)显着降低至SmtO
2指导管理组的24％(44/183)(风险比为0.58[95％CI，0.42至0.80]；p<0.001)，对应于绝对风险降低了17％，相对风险降低了42％(表5)。
Patients with a body mass index (BMI) ≥25 had a significantly lower 24-hour PONV rate from 41% (66/160) in the conventional management group to 24% (44/183) in the SmtO2 - guided management group (hazard ratio 0.58[ 95% CI, 0.42 to 0.80]; p<0.001), corresponding to a 17% absolute risk reduction and a 42% relative risk reduction (Table 5).
如图3所示的，预先指定的亚组中PONV的风险比BMI(以公斤为单位的体重除以米为单位的身高的平方)≥25的患者的24小时PONV率在组间存在显着差异(p<0.001)，在进行多次比较调整后，p值仍然很显着。在进行多次比较调整后，基线血红蛋白水平≥126g/L的患者的24小时PONV率的组间差异无统计学意义。As shown in Figure 3, the 24-hour PONV rates of patients with a hazard ratio of PONV in prespecified subgroups with a BMI (weight in kilograms divided by height in meters squared) ≥ 25 were significantly different between groups. Differences (p<0.001), p-values remained significant after adjustment for multiple comparisons. After adjustment for multiple comparisons, there was no statistically significant between-group difference in 24-hour PONV rates among patients with baseline hemoglobin levels ≥126 g/L.
表1 基线时统计的管理对象和围手术期特征
a
Table 1 Statistical management objects and perioperative characteristics at baselinea
备注：a.SmtO
2表示肌肉组织氧饱和度，PONV表示术后恶心和呕吐，IQR表示四分位间距，AUC表示曲线下面积和NA表示不适用。
Remarks: a. SmtO 2 means muscle tissue oxygen saturation, PONV means postoperative nausea and vomiting, IQR means interquartile range, AUC means area under the curve and NA means not applicable.
b ASA的身体状况标准包括正常健康分类(I)，轻度全身性疾病(II)和重度全身性疾病(III)。b Physical status criteria for ASA include categories of normal health (I), mild systemic disease (II) and severe systemic disease (III).
c有关。c related.
表2 手术围手术期的干预和测量Table 2 Perioperative Interventions and Measurements
备注：a.SmtO
2表示肌肉组织的氧饱和度，IQR四分位数范围和曲线下的AUC面积。
Remarks: a. SmtO 2 represents oxygen saturation of muscle tissue, IQR interquartile range and AUC area under the curve.
b在SmtO
2指导的管理组中，一名患者缺少有关基线侧腹或前臂SmtO
2测量的数据。
bIn the SmtO2 - guided management group, one patient had missing data on baseline flank or forearm SmtO2 measurements.
c数据丢失超过50％或数据记录时间少于20分钟的患者被排除在分析之外。cPatients with data loss of more than 50% or data recording time of less than 20 min were excluded from the analysis.
d在SmtO
2指导治疗组中有6例患者和在常规治疗组中有9例患者缺少有关侧腹SmtO
2AUC<基线和目标(基线或70％)的数据。
d Data on flank SmtO 2 AUC < baseline and target (baseline or 70%) were missing for 6 patients in the SmtO 2 -guided treatment group and 9 patients in the usual care group.
e在SmtO
2指导治疗组中有5例患者和在常规治疗组中有9例患者缺少有关侧腹SmtO
2AUC<70％的数据。
eData on flank SmtO 2 AUC <70% were missing for 5 patients in the SmtO 2 -guided treatment group and 9 patients in the usual care group.
f在SmtO
2指导治疗组中有6例患者和在常规治疗组中有8例患者缺少有关前臂SmtO
2AUC<基线和目标(基线或70％)的数据。
f Data on forearm SmtO 2 AUC < baseline and target (baseline or 70%) were missing for 6 patients in the SmtO 2 -guided treatment group and 8 patients in the usual care group.
g在SmtO
2指导治疗组中有5例患者和在常规治疗组中有8例患者缺少有关前臂SmtO
2AUC<70％的数据。
gData on forearm SmtO 2 AUC <70% were missing for 5 patients in the SmtO 2 -guided treatment group and 8 patients in the usual care group.
h在SmtO
2指导的管理组中有1名患者和在常规管理组中有2名患者缺少有关基线心脏指数，每搏率和全身血管阻力的数据。
h Data on baseline cardiac index, stroke rate, and systemic vascular resistance were missing for 1 patient in the SmtO2 - guided management group and 2 patients in the usual management group.
i在SmtO
2指导的管理组中，缺少1名患者的有关基线心率，收缩压，舒张压和平均血压的数据。
iIn the SmtO2 - guided management group, data on baseline heart rate, systolic, diastolic and mean blood pressure were missing for 1 patient.
j在SmtO
2指导治疗组中有21例患者缺少心脏指数AUC<基线的数据，而在常规治疗组中则缺少31例患者的心脏指数。
j Data on cardiac index AUC < baseline were missing for 21 patients in the SmtO2 - guided treatment group and 31 patients in the usual care group.
k在SmtO
2指导治疗组中有20例患者和在常规治疗组中有30例患者缺少有关每搏率和全身血管阻力AUC<基线的数据。
kData on stroke rate and systemic vascular resistance AUC < baseline were missing for 20 patients in the SmtO 2 -guided treatment group and 30 patients in the usual care group.
l在SmtO
2指导治疗组中有20例患者和在常规治疗组中有29例患者缺少有关心率，收缩压，舒张压和平均血压AUC<基线的数据。
lData on heart rate, systolic blood pressure, diastolic blood pressure and mean blood pressure AUC<baseline were missing for 20 patients in the SmtO2 - guided treatment group and 29 patients in the usual care group.
m根据Holm-Bonferroni方法进行多次比较调整后，p值不显着，中位心脏指数AUC的阈值水平为p＝0.0018，收缩压中位数AUC的阈值水平为p＝0.0019，中位数为p＝0.0019舒张压AUC。mAdjusted for multiple comparisons according to the Holm-Bonferroni method, the p-value was not significant, the threshold level for the median cardiac index AUC was p=0.0018, the threshold level for the median systolic blood pressure AUC was p=0.0019, and the median was p = 0.0019 diastolic AUC.
表3 主要和次要结果
a
Table 3 Primary and secondary resultsa
备注：Remark:
a.SmtO
2表示肌肉组织氧饱和度，PONV表示术后恶心和呕吐，IQR表示四分位间距，AUC表示曲线下面积和NA表示不适用。
a. SmtO2 indicates muscle tissue oxygen saturation, PONV indicates postoperative nausea and vomiting, IQR indicates interquartile range, AUC indicates area under the curve and NA indicates not applicable.
b SmtO
2指导管理组的风险比是普通管理组；组间差异基于Hodges-Lehmann估计量。
b Hazard ratios for the SmtO 2 -guided management group are for the usual management group; differences between groups are based on Hodges-Lehmann estimators.
c使用数字评分量表(NRS)评估恶心和疼痛的严重程度，该评分标准为11分制，其中0表示无恶心或疼痛，而10表示最严重的恶心或疼痛。得分≥5表示中度至重度恶心或疼痛。c Severity of nausea and pain was assessed using the Numeric Rating Scale (NRS) on an 11-point scale, where 0 indicates no nausea or pain and 10 indicates the worst nausea or pain. A score ≥5 indicates moderate to severe nausea or pain.
d根据Holm-Bonferroni方法进行多次比较调整后，p值不显着，手术后前2h的中度至重度恶心阈值p＝0.0013，比率p＝0.0014术后头24小时内中度至重度恶心的百分比，“能够享用食物”的p＝0.0014，“感觉休息”的p＝0.0012，“感觉舒适且在控制中”的p＝0.0013，p＝“具有一般的幸福感”为0.0013，CoR-15A部分得分为p＝0.0013，第一夜睡眠的质量为p＝0.0014。d After adjusting for multiple comparisons according to the Holm-Bonferroni method, the p value was not significant, the threshold of moderate to severe nausea in the first 2 hours after surgery p = 0.0013, the ratio p = 0.0014 of moderate to severe nausea in the first 24 hours after surgery Percentage, p = 0.0014 for "Able to enjoy food", p = 0.0012 for "Feeling rested", p = 0.0013 for "Feeling comfortable and in control", p = 0.0013 for "Have a general sense of well-being", CoR-15A section Score was p=0.0013, quality of first night's sleep was p=0.0014.
e在SmtO
2指导的管理组中有1名患者和在常规管理组中有1名患者缺少有关QoR-15的数据。
e Data on QoR-15 were missing for 1 patient in the SmtO2 - guided management group and 1 patient in the usual management group.
f根据0到10的等级来评估第一夜睡眠的质量，其中0＝无时间[差]和10＝所有时间[优秀]。在SmtO
2指导的管理组中，有1名患者缺少有关首次夜间睡眠质量的数据。
f The quality of the first night's sleep was assessed on a scale of 0 to 10, where 0 = no time [poor] and 10 = all time [excellent]. Data on first night's sleep quality were missing for 1 patient in the SmtO2 - guided management group.
g SmtO
2指导治疗组的3例患者和常规治疗组的2例患者缺少有关首次起床时间的数据。
g Data on time to first wake up were missing for 3 patients in the SmtO 2 -guided treatment group and 2 patients in the usual care group.
h有关耐受第一个p.o时间的数据。对照组中缺失4例患者数据。h Data on time to first p.o. The data of 4 patients in the control group were missing.
i肠梗阻发生在常规管理组的1名患者中。iIleus occurred in 1 patient in the usual management group.
j在SmtO
2指导治疗组中有1例患者发生了深静脉血栓形成，在常规治疗组中有2例患者发生了深静脉血栓形成。
jDeep vein thrombosis occurred in 1 patient in the SmtO2 - guided treatment group and in 2 patients in the usual care group.
k SmtO
2指导的管理组中有1名患者发生伤口裂开。
k Wound dehiscence occurred in 1 patient in the SmtO 2 -guided management group.
l SmtO
2指导的管理组中有1位患者发生了***；SmtO
2指导治疗组中有1例发生了手术部位感染，而常 规治疗组中有3例发生了手术部位感染。
l One patient in the SmtO2 - guided management group had a urinary tract infection; one patient in the SmtO2 - guided treatment group had a surgical site infection, and three patients in the usual care group had a surgical site infection.
表4 BMI≥25
a的管理对象的手术围手术期的干预和测量
Table 4 Perioperative intervention and measurement of surgical subjects with BMI≥25a
备注：a.SmtO
2表示肌肉组织的氧饱和度，IQR四分位数范围和曲线下的AUC面积。
Remarks: a. SmtO 2 represents oxygen saturation of muscle tissue, IQR interquartile range and AUC area under the curve.
b在SmtO
2指导的管理组中，没有关于基线侧腹或前臂SmtO
2测量数据的丢失。
b In the SmtO2 - guided management group, there was no loss of data on baseline flank or forearm SmtO2 measurements.
c数据丢失超过50％或数据记录时间少于20分钟的患者被排除在分析之外。cPatients with more than 50% data loss or data recording time less than 20 min were excluded from the analysis.
d在SmtO
2指导治疗组中有2例患者和在常规治疗组中有3例患者缺少有关侧腹SmtO
2AUC<基线和目标(基线或70％)的数据。
d Data on flank SmtO 2 AUC < baseline and target (baseline or 70%) were missing for 2 patients in the SmtO 2 -guided treatment group and 3 patients in the usual care group.
e在SmtO
2指导治疗组中有2例患者和在常规治疗组中有3例患者缺少有关侧腹SmtO
2AUC<70％的数据。
eData on flank SmtO 2 AUC <70% are missing for 2 patients in the SmtO 2 -guided treatment group and 3 patients in the usual care group.
f在SmtO
2指导治疗组中有2例患者和在常规治疗组中有3例患者缺少有关前臂SmtO
2AUC<基线和目标(基线或70％)的数据。
f Data on forearm SmtO 2 AUC < baseline and target (baseline or 70%) were missing for 2 patients in the SmtO 2 -guided treatment group and 3 patients in the usual care group.
g在SmtO
2指导治疗组中有2例患者和在常规治疗组中有3例患者缺少有关前臂SmtO
2AUC<70％的数据。
gData on forearm SmtO 2 AUC <70% were missing for 2 patients in the SmtO 2 -guided treatment group and 3 patients in the usual care group.
h在常规管理组中有2名患者缺少有关基线心脏指数，每搏率和全身血管阻力的数据。h Data on baseline cardiac index, stroke rate, and systemic vascular resistance were missing for 2 patients in the usual management group.
i没有缺失关于基线心率，收缩压，舒张压和平均血压的数据。i No missing data on baseline heart rate, systolic, diastolic and mean blood pressure.
j SmtO
2指导治疗组中的8例患者和常规治疗组中的12例患者缺少有关心脏指数AUC<基线的数据。
j Data on cardiac index AUC < baseline were missing for 8 patients in the SmtO 2 -guided treatment group and 12 patients in the usual care group.
k在SmtO
2指导治疗组中有8例患者和在常规治疗组中有12例患者缺少有关每搏率和全身血管阻力AUC<基线的数据。
kData on stroke rate and systemic vascular resistance AUC < baseline were missing for 8 patients in the SmtO 2 -guided treatment group and 12 patients in the usual care group.
l在SmtO
2指导治疗组中有8例患者和在常规治疗组中有11例患者缺少有关心率，收缩压，舒张压和平均血压AUC<基线的数据。
l Data on heart rate, systolic blood pressure, diastolic blood pressure and mean blood pressure AUC<baseline were missing for 8 patients in the SmtO2 - guided treatment group and 11 patients in the usual care group.
m根据Holm-Bonferroni方法进行多次比较调整后，p值不显着，中位数尿量阈值为p＝0.0019，中位心脏指数AUC为p＝0.0019，中位心律为p＝0.0018AUC。m Adjusted for multiple comparisons according to the Holm-Bonferroni method, the p-values were not significant, the median urine volume threshold was p=0.0019, the median cardiac index AUC was p=0.0019, and the median heart rate was p=0.0018AUC.
表5 BMI≥25
a的管理对象的主要和次要结果
Table 5 Primary and secondary results of managed objects with BMI≥25 a
备注：Remark:
a.SmtO
2表示肌肉组织氧饱和度，PONV表示术后恶心和呕吐，IQR表示四分位间距，AUC表示曲线下面积和NA表示不适用。
a. SmtO2 indicates muscle tissue oxygen saturation, PONV indicates postoperative nausea and vomiting, IQR indicates interquartile range, AUC indicates area under the curve and NA indicates not applicable.
b SmtO
2指导管理组的风险比是普通管理组；组间差异基于Hodges-Lehmann估计量。
b Hazard ratios for the SmtO 2 -guided management group are for the usual management group; differences between groups are based on Hodges-Lehmann estimators.
c使用数字评分量表(NRS)评估恶心和疼痛的严重程度，该评分标准为11分制，其中0表示无恶心或疼痛， 而10表示最严重的恶心或疼痛。得分≥5表示中度至重度恶心或疼痛。c Severity of nausea and pain was assessed using the Numeric Rating Scale (NRS) on an 11-point scale, where 0 indicates no nausea or pain and 10 indicates the worst nausea or pain. A score ≥5 indicates moderate to severe nausea or pain.
d在基于Holm-Bonferroni方法进行多次比较调整后，p值不显着，手术后前2h的PONV率阈值为p＝0.0014，6-24h的PONV率阈值为p＝0.0015手术后，术后2小时内中度至重度恶心的发生率p＝0.0018，术后24小时内中度至重度恶心的发生率p＝0.0014表示“能够享受食物”，p＝0.0019表示“睡眠良好”，p＝0.0015表示“能够独立照顾个人洗手间和卫生”，p＝0.0015表示“感觉舒适且有控制感”，p＝0.0015表示“拥有良好的睡眠感觉”，CoR-15A部分得分为p＝0.0014，“恶心或呕吐”为p＝0.0015。d After adjusting for multiple comparisons based on the Holm-Bonferroni method, the p value is not significant, the PONV rate threshold for the first 2 hours after surgery is p = 0.0014, and the PONV rate threshold for 6-24 hours is p = 0.0015 After surgery, after 2 hours p=0.0018 for moderate to severe nausea within hours, p=0.0014 for “able to enjoy food,” p=0.0019 for “sleep well,” and p=0.0015 for moderate to severe nausea within 24 hours after surgery "Able to take care of personal toilet and hygiene independently", p = 0.0015 for "feeling comfortable and in control", p = 0.0015 for "having a good sleep feeling", p = 0.0014 for the CoR-15A part score, "nausea or vomiting" was p=0.0015.
e在SmtO
2指导的管理组中有1名患者缺少有关QoR-15的数据。
eData on QoR-15 are missing for 1 patient in the SmtO2 - guided management arm.
f根据0到10的等级来评估第一夜睡眠的质量，其中0＝无时间[差]和10＝所有时间[优秀]。在SmtO
2指导的管理组中，有1名患者缺少有关首次夜间睡眠质量的数据。
f The quality of the first night's sleep was assessed on a scale of 0 to 10, where 0 = no time [poor] and 10 = all time [excellent]. Data on first night's sleep quality were missing for 1 patient in the SmtO2 - guided management group.
g SmtO
2指导治疗组的1例患者和常规治疗组的1例患者缺少有关首次起床时间的数据。
g Data on time to first wake up were missing for 1 patient in the SmtO 2 -guided treatment group and 1 patient in the usual care group.
h有关耐受第一个p.o时间的数据。对照组中缺失1例患者数据。h Data on time to first p.o. The data of 1 patient in the control group were missing.
i深静脉血栓形成在SmtO
2指导治疗组中发生1例，在常规治疗组中发生1例。
iDeep vein thrombosis occurred in 1 case in the SmtO 2 -guided treatment group and 1 case in the usual treatment group.
j SmtO
2指导治疗组中有1例发生手术部位感染，而常规治疗组中有2例发生手术部位感染。
jSurgical site infection occurred in 1 case in the SmtO 2 -guided treatment group and 2 cases in the usual care group.
上述表3和表5中各术语解释和定义如下：The explanations and definitions of the terms in the above Tables 3 and 5 are as follows:
1.PONV定义：1. PONV definition:
恶心：恶心被定义为与呕吐的欲望相关的主观不适感。恶心应该由患者而不是观察者来评估。最好将这种感觉描述为在没有剧烈肌肉运动的情况下进行呕吐的愿望。Nausea: Nausea is defined as a subjective feeling of discomfort associated with the desire to vomit. Nausea should be assessed by the patient rather than the observer. This feeling is best described as a desire to vomit without vigorous muscle movement.
当恶心加剧时，唾液分泌增加，并与血管舒缩功能障碍和出汗有关。When nausea is exacerbated, salivation increases and is associated with vasomotor dysfunction and sweating.
作呕：作呕被定义为在不排出胃内容物的情况下，胸肌和腹肌的劳动性，痉挛性和节律性收缩。作呕和呕吐的区别在于即使是最小量的胃内容物也会产生。如果没有排出胃中的内容，则将驱逐努力归类为作呕。作呕通常表示胃空了，并且通常使病人不舒服。Gagging: Gagging is defined as laborious, spastic, and rhythmic contractions of the pectoral and abdominal muscles without expulsion of gastric contents. The difference between gagging and vomiting is that even the smallest amount of stomach contents is produced. If the contents of the stomach are not expelled, the expulsion effort is classified as gagging. Nausea usually indicates an empty stomach and usually makes the patient uncomfortable.
呕吐：呕吐是指从口腔中强行驱逐任何胃内容物。Vomiting: Vomiting is the forcible expulsion of any stomach contents from the mouth.
PONV：PONV是指恶心，作呕和/或呕吐的发生。PONV: PONV refers to the occurrence of nausea, gagging and/or vomiting.
2.PONV评估2. PONV evaluation
§PONV将在术后2、6和24小时进行评估(3次)。§PONV will be assessed at 2, 6, and 24 hours postoperatively (3 times).
§记录术后0-2、2-6和6-24小时出现的PONV。§ PONV that occurred 0-2, 2-6, and 6-24 hours postoperatively was recorded.
§24小时PONV定义为术后24小时内PONV的发生率。§24-hour PONV was defined as the incidence of PONV within 24 hours after surgery.
§将记录PONV的发生，子类型和严重性。§ The occurrence, subtype and severity of PONV will be documented.
§将使用0-10的数字评分量表(NRS)来量化恶心，其中0＝无，10＝最坏的。§ Nausea will be quantified using a Numeric Rating Scale (NRS) of 0-10, where 0=none and 10=worst.
§如果患者在手术后24小时之前出院，则结果评估者应致电患者专门评估PONV。§ If the patient is discharged before 24 hours after surgery, the outcome assessor should call the patient specifically to evaluate PONV.
§主要终点是手术后24小时内的PONV率。§ The primary endpoint was the rate of PONV within 24 hours of surgery.
3.术后疼痛评估3. Postoperative pain assessment
§在与PONV相同的时间点(即手术后2小时，6小时和24小时)评估疼痛。用于恶心评估的相同NRS(0-10评分，其中0表示没有疼痛，10表示最严重的疼痛)将用于评估疼痛的严重程度。§ Pain was assessed at the same time points as in PONV (i.e., 2 hours, 6 hours, and 24 hours after surgery). The same NRS (0-10 scale, where 0 represents no pain and 10 represents the worst pain) used for nausea assessment will be used to assess pain severity.
4.睡眠质量评估4. Sleep quality assessment
手术后第一夜睡眠的质量将使用0-10NRS进行评估(0表示最差的睡眠，而10表示最佳的睡眠)The quality of the first night's sleep after surgery will be rated using the 0-10 NRS (0 being the worst sleep and 10 being the best sleep)
5.移动5. Move
§步行能力的定义是患者在有或没有帮助的情况下下床行走的能力。§Ambulation was defined as the patient's ability to get out of bed and walk with or without assistance.
§将记录从手术结束到第一次下床的时间。§ The time from the end of the procedure to the first time out of bed will be recorded.
§记录术后48小时的下肢活动情况。§Record the activity of lower limbs 48 hours after operation.
6.胃肠道恢复及并发症6. Gastrointestinal recovery and complications
§整个术后期间将评估胃肠道恢复情况和并发症。§Gastrointestinal recovery and complications will be assessed throughout the postoperative period.
§胃肠功能的恢复是通过对口中食物的耐受能力(耐受性)来表明的。§Recovery of gastrointestinal function is indicated by the ability to tolerate food in the mouth (tolerance).
§从手术结束到大便的时间公差将被记录。§ The time tolerance from the end of the procedure to the stool will be recorded.
§发生p.o.手术后48小时会记录耐受性。§ Tolerance will be recorded 48 hours after the occurrence of p.o. surgery.
§与胃肠道相关的并发症包括肠梗阻，阻塞，穿孔和出血。定义如下。§ Gastrointestinal-related complications include ileus, obstruction, perforation, and hemorrhage. It is defined as follows.
肠梗阻是肠蠕动的暂时性停止。肠梗阻的症状和体征包括腹胀，恶心，呕吐和模糊的不适。疼痛很少在机械性阻塞中具有经典的绞痛模式。可能有便秘或少量水样便通过。听诊显示腹部无声或蠕动最小。除非根本原因是炎症，否则腹部不柔软。肠梗阻最常发生在腹部手术后，尤其是在肠道***纵后。症状是恶心，呕吐和模糊的腹部不适。诊断基于X射线检查结果和临床印象。用鼻胃抽吸液和静脉输液支持治疗。Ileus is a temporary cessation of bowel movement. Symptoms and signs of intestinal obstruction include bloating, nausea, vomiting, and vague discomfort. Pain rarely has the classic colic pattern in mechanical obstruction. May have constipation or pass light watery stools. Auscultation revealed silent or minimal abdominal movements. The abdomen is not tender unless the underlying cause is inflammation. Bowel obstruction most often occurs after abdominal surgery, especially after the bowel has been manipulated. Symptoms are nausea, vomiting, and vague abdominal discomfort. Diagnosis is based on X-ray findings and clinical impressions. Supportive treatment with nasogastric aspirates and intravenous fluids.
肠梗阻是严重的机械损伤或由于病理原因导致肠阻塞而完全阻止了内容物通过肠道。症状包括绞痛，呕吐，便秘和肠胃气胀。诊断是临床的，经腹部X线检查证实。治疗包括液体复苏，鼻胃抽吸，以及在大多数情况下完全阻塞的手术。Ileus is severe mechanical injury or intestinal obstruction due to pathological causes that completely prevents the passage of contents through the intestinal tract. Symptoms include cramping, vomiting, constipation and flatulence. Diagnosis is clinical and confirmed by abdominal radiography. Treatment includes fluid resuscitation, nasogastric aspiration, and in most cases surgery for complete obstruction.
胃肠道的急性穿孔。胃肠道的任何部分都可能打孔，将胃或肠内容物释放到腹膜空间。原因多种多样。症状突然发作，剧烈疼痛，不久后出现休克迹象。诊断通常是通过影像学检查发现腹部有游离空气来进行的。治疗包括液体复苏，抗生素和手术。死亡率很高，取决于潜在的疾病和患者的总体健康状况。Acute perforation of the gastrointestinal tract. Perforation may occur in any part of the GI tract, releasing gastric or intestinal contents into the peritoneal space. There are various reasons. Symptoms come on suddenly, with severe pain, followed by signs of shock shortly after. Diagnosis is usually made by finding free air in the abdomen on imaging studies. Treatment includes fluid resuscitation, antibiotics, and surgery. Mortality is high and depends on the underlying disease and the patient's general health.
·胃肠道出血。胃肠道出血可起源于从口腔到***的任何地方，并且可能是明显的或隐匿的。表现取决于出血的部位和发生率。· Gastrointestinal bleeding. Gastrointestinal bleeding can originate anywhere from the mouth to the anus and may be overt or insidious. Manifestations depend on the site and frequency of bleeding.
7.非胃肠道并发症7. Non-gastrointestinal complications
器官/***并发症Organ/System Complications
□呼吸功能不全(低氧血症或高碳酸血症，术后任何持续时间都需要机械通气)□ Respiratory insufficiency (hypoxemia or hypercapnia, requiring mechanical ventilation for any duration after surgery)
□肺栓塞(经临床表现和影像学检查证实)□Pulmonary embolism (confirmed by clinical manifestations and imaging examinations)
□急性心肌梗塞(肌钙蛋白T浓度增加到超过医院实验室的心肌梗塞阈值，并且ST-T段出现新的Q波(持续时间至少为0.03秒)或持续变化(4天))□ Acute myocardial infarction (increased troponin T concentration above the hospital laboratory's myocardial infarction threshold, and new Q waves (duration of at least 0.03 seconds) or persistent changes (4 days) in the ST-T segment)
□循环***功能不全(手术后任何时间内都需要使用促力剂或升压药)□Circulatory insufficiency (need to use nootropic or pressor drugs at any time after surgery)
□新发生的心律失常(通过12导联心电图确认并需要治疗和/或心脏复律)□ New onset arrhythmia (confirmed by 12-lead ECG and requiring treatment and/or cardioversion)
□中风(持续存在新的局灶性神经功能缺损，并通过神经影像学检查证实)□Stroke (persistent new focal neurological deficit, confirmed by neuroimaging)
□急性肾损伤□ Acute kidney injury
(KDIGO将急性肾损伤定义为以下任何一种：(KDIGO defines acute kidney injury as any of the following:
·48小时内血清肌酐增加0.3mg/dL或更多，或An increase in serum creatinine of 0.3 mg/dL or more within 48 hours, or
·最近7天内血清肌酐增加至基线的1.5倍或更多，或Serum creatinine increased to 1.5 times baseline or more within the last 7 days, or
·6小时内尿液排量少于0.5mL/kg/小时Urine output less than 0.5 mL/kg/hour within 6 hours
□深静脉血栓形成(经静脉超声/静脉造影证实)□Deep vein thrombosis (confirmed by venous ultrasound/venous contrast)
□弥散性血管内凝血(表现为异常出血，以及凝血酶原时间延长/部分凝血活酶活化)，血小板/纤维蛋白原水平降低以及纤维蛋白降解产物(包括D-二聚体)增加)□Disseminated intravascular coagulation (manifested by abnormal bleeding, and prolonged prothrombin time/partial thromboplastin activation), decreased platelet/fibrinogen levels, and increased fibrin degradation products (including D-dimer)
手术并发症surgical complications
□伤口裂开(需要二次缝合的伤口破裂)□Wound dehiscence (wound rupture requiring secondary suturing)
□切口疝(需要二次手术)□ Incisional hernia (requires secondary surgery)
□手术出血(术后出血需要二次手术止血)□ Surgical bleeding (postoperative bleeding requires secondary surgery to stop bleeding)
□吻合口渗漏(需要经皮引流的体腔或腹膜后腔内造影剂外渗)□Anastomotic leakage (extravasation of contrast agent in body cavity or retroperitoneal cavity requiring percutaneous drainage)
传染性并发症infectious complications
□严重的败血症/败血性休克(两种或多种标准的全身性炎症反应综合征，已知感染和至少一种***的新发功能障碍或需要维持血压的升压药)□Severe sepsis/septic shock (two or more of standard systemic inflammatory response syndrome, known infection and new-onset dysfunction of at least one system or need for vasopressors to maintain blood pressure)
□腹腔内脓肿(经超声或CT扫描证实，需要经皮引流)□Intra-abdominal abscess (confirmed by ultrasound or CT scan, requiring percutaneous drainage)
□肺部感染(胸部X线照片上出现新的浸润，并伴有摄氏38度以上的温度和白细胞增多)□Pulmonary infection (new infiltrates on chest radiograph with temperature above 38°C and leukocytosis)
□伤口感染(切口表达脓液，脓液培养细菌)□Wound infection (incision expresses pus, pus cultures bacteria)
□***(经尿液分析和尿培养证实，需要抗生素治疗)□Urinary tract infection (confirmed by urinalysis and urine culture, requiring antibiotic treatment)
8.住院时间8. Length of hospital stay
§此变量定义为手术后患者在医院停留的总小时数。§ This variable was defined as the total number of hours the patient stayed in the hospital after surgery.
9.进入ICU9. Enter the ICU
§此变量定义为手术后患者是否因任何原因被送入ICU。§ This variable was defined as whether the patient was admitted to the ICU for any reason after surgery.
10. 30天随访10. 30-day follow-up
§将通过电话对所有患者进行随访，以评估再次入院，死亡率和任何并发症的发生。§All patients will be followed up by telephone to assess readmission, mortality, and occurrence of any complications.
总之，在接受腹腔镜子宫切除术的相对年轻且健康的女性患者中，手术期间SmtO
2指导的管理可有效治疗SmtO
2的降低，但与常规管理相比，虽没有显着降低24小时PONV率。但是，SmtO
2指导的管理可能能够显着降低BMI≥25的患者的PONV风险。此外，这种管理方法可能能够促进手术后的恢复。本发明创新的，个性化的，基于血流动力学、基于组织灌注和氧合数据的管理、处理和分析方法具有显著的优势。
In conclusion, in relatively young and healthy female patients undergoing laparoscopic hysterectomy, intraoperative SmtO2 - guided management was effective in treating the decrease in SmtO2 , although it did not significantly reduce the 24-hour PONV rate compared with usual management . However, SmtO2 - guided management may be able to significantly reduce the risk of PONV in patients with BMI ≥25. In addition, this management approach may be able to facilitate recovery after surgery. The innovative, personalized, hemodynamic-based, tissue perfusion-based and oxygenation-based data management, processing and analysis methods of the present invention have significant advantages.
以上，对本发明的实施方式进行了说明。但是，本发明不限定于上述实施方式。凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。The embodiments of the present invention have been described above. However, the present invention is not limited to the above-mentioned embodiments. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.
Claims (10)
- 一种围手术期用管理装置，其特征在于，所述管理装置包括：信息采集模块、数据处理模块和显示模块；A perioperative management device, characterized in that the management device includes: an information collection module, a data processing module and a display module;所述信息采集模块用于采集管理对象的体征信息，例如肌肉组织氧信息和/血流动力学体征信息；The information collection module is used to collect the sign information of the management object, such as muscle tissue oxygen information and/hemodynamic sign information;所述数据处理模块与信息采集模块连接，其用于接收与处理管理对象的体征信息，以使其转化为体征参数，例如肌肉组织氧参数和血流动力学参数。The data processing module is connected with the information collection module, which is used to receive and process the sign information of the management object, so as to convert it into sign parameters, such as muscle tissue oxygen parameters and hemodynamic parameters.
- 根据权利要求1所述的围手术期用管理装置，其特征在于，所述信息采集模块包含信号采集模块，所述信号采集模块用于采集管理对象的体征信号，例如肌肉组织氧信号和/或血流动力学体征信号；The perioperative management device according to claim 1, wherein the information collection module includes a signal collection module, and the signal collection module is used to collect signs and signals of the managed object, such as muscle tissue oxygen signals and/or Hemodynamic signs and signals;优选地，所述数据处理模块还能够将所述体征参数中的一种或多种与参比参数进行比较；Preferably, the data processing module is also capable of comparing one or more of the sign parameters with reference parameters;优选地，所述数据处理模块能够存储或可被输入参比参数；Preferably, said data processing module is capable of storing or may be input with reference parameters;优选地，通过所述数据处理模块来分析肌肉组织氧参数、血流动力学参数与各参数基线值或者目标曲线下面积之间的关系；Preferably, the data processing module is used to analyze the relationship between muscle tissue oxygen parameters, hemodynamic parameters and the baseline value of each parameter or the area under the target curve;优选地，通过所述数据处理模块的分析结果，确定是否进入管理模式或进入下一参数判断模式。Preferably, according to the analysis result of the data processing module, it is determined whether to enter the management mode or enter the next parameter judgment mode.
- 根据权利要求1或2所述的围手术期用管理装置，其特征在于，所述显示模块与数据处理模块连接，用于显示数据处理模块输出的可视化数据；The perioperative management device according to claim 1 or 2, wherein the display module is connected to the data processing module for displaying the visualized data output by the data processing module;优选地，所述肌肉组织氧(SmtO 2)选自侧腹SmtO 2、前臂SmtO 2和/或下肢SmtO 2； Preferably, the muscle tissue oxygen (SmtO 2 ) is selected from flank SmtO 2 , forearm SmtO 2 and/or lower limb SmtO 2 ;优选地，所述血流动力学体征包括心排量(CO)和血压(BP)；其中，所述心排量的决定因素包括每搏率(SV)和心率(HR)，所述血压的决定因素包括心排量和***性血管阻力(SVR)。Preferably, the hemodynamic signs include cardiac output (CO) and blood pressure (BP); wherein, the determinants of the cardiac output include stroke rate (SV) and heart rate (HR), the blood pressure Determinants include cardiac output and systemic vascular resistance (SVR).优选地，所述信息采集模块或信号采集模块包括信号采集器，用于采集对象的至少体征信号，例如肌肉组织氧信号和/或血流动力学体征信号。Preferably, the information collection module or signal collection module includes a signal collector for collecting at least a sign signal of the subject, such as a muscle tissue oxygen signal and/or a hemodynamic sign signal.优选地，所述信号采集器包括用于第一信号采集器、第二信号采集器、第三信号采集器、第四信号采集器和/或第五信号采集器；Preferably, the signal collector includes a first signal collector, a second signal collector, a third signal collector, a fourth signal collector and/or a fifth signal collector;所述第一信号采集器用于采集侧腹SmtO 2，所述第二信号采集器用于采集前臂SmtO 2，所述第三信号采集器用于采集血压信号，所述第四信号采集器用于采集每搏率(SV)，所述第五信号采集器用于采集心率(HR)。 The first signal collector is used to collect flank SmtO 2 , the second signal collector is used to collect forearm SmtO 2 , the third signal collector is used to collect blood pressure signals, and the fourth signal collector is used to collect heart rate (SV), the fifth signal collector is used to collect heart rate (HR).优选地，所述信号采集器包括直接采集体征信号的传感器。Preferably, the signal collector includes a sensor that directly collects the sign signal.
- 根据权利要求1-3任一项所述的围手术期用管理装置，其特征在于，所述数据处理模块包括肌肉组织氧数据处理模块和与肌肉组织氧数据处理模块连接的血流动力学参数数据处理模块；The perioperative management device according to any one of claims 1-3, wherein the data processing module includes a muscle tissue oxygen data processing module and a hemodynamic parameter connected to the muscle tissue oxygen data processing module Data processing module;优选地，所述数据处理模块包括信号处理器，用于接收与处理信号采集器中传感器采集的信号。Preferably, the data processing module includes a signal processor for receiving and processing the signals collected by the sensors in the signal collector.优选地，所述信号处理器包括第一信号处理器和第二信号处理器，所述第一信号处理器设置在肌肉组织氧数据处理模块中，所述第二信号处理器设置在血流动力学参数数据处理模块。优选第一信号处理器用于将管理对象的肌肉组织氧信号转化为对应的参数，第二信号处理器用于将管理对象的血流动力学参数信号转化为对应的参数。Preferably, the signal processor includes a first signal processor and a second signal processor, the first signal processor is set in the muscle tissue oxygen data processing module, and the second signal processor is set in the hemodynamic Learning parameter data processing module. Preferably, the first signal processor is used to convert the muscle tissue oxygen signal of the managed subject into corresponding parameters, and the second signal processor is used to convert the hemodynamic parameter signal of the managed subject into corresponding parameters.优选地，所述肌肉组织氧数据处理模块包括并列的侧腹SmtO 2数据处理模块和前臂SmtO 2数据处理模块；当至少一个数据处理模块中的SmtO 2监测值<70％(或者<75％)或低于其基线值(优选以二者数值中的较高者为准)，并持续时间≥60s时，则开始进入血流动力学参数数据处理模块；若否，则保持继续监测状态。 Preferably, the muscle tissue oxygen data processing module includes a side abdomen SmtO 2 data processing module and a forearm SmtO 2 data processing module; when the SmtO 2 monitoring value in at least one data processing module is <70% (or <75%) or lower than its baseline value (preferably the higher of the two values) for a duration ≥ 60s, start to enter the hemodynamic parameter data processing module; if not, maintain the continuous monitoring state.
- 根据权利要求4所述的围手术期用管理装置，其特征在于，所述血流动力学参数数据处理模块包括顺次连接的心排量数据处理模块、***性血管阻力数据处理模块和血压数据处理模块；当监测值 与该参数的基线值之间的关系判断为“否”时，则提示进入下一参数判断模式；当为“是”时，则提示进入管理模式；其中的“否”分为达到预设数值和未达到预设数值两种情况，取决于待判断的体征参数。The perioperative management device according to claim 4, wherein the hemodynamic parameter data processing module includes a sequentially connected cardiac output data processing module, a systemic vascular resistance data processing module, and a blood pressure data processing module. Processing module; when the relationship between the monitoring value and the baseline value of the parameter is judged as "no", it will prompt to enter the next parameter judgment mode; when it is "yes", it will prompt to enter the management mode; the "no" It can be divided into two situations: reaching the preset value and not reaching the preset value, depending on the sign parameters to be judged.
- 根据权利要求5所述的围手术期用管理装置，其特征在于，所述心排量数据处理模块包括并列且互连的心率数据处理模块和每搏率数据处理模块；The perioperative management device according to claim 5, wherein the cardiac output data processing module includes a parallel and interconnected heart rate data processing module and a beat rate data processing module;优选地，所述每搏率数据处理模块包括并列的前负荷数据处理模块、后负荷数据处理模块和收缩力数据处理模块，前负荷数据处理模块和后负荷数据处理模块分别与收缩力数据处理模块连接；Preferably, the beat rate data processing module includes an anterior load data processing module, an afterload data processing module and a contraction force data processing module that are paralleled. connect;优选地，当所述心排量数据处理模块的监测值达到该参数的基线值时，则提示查看每搏率数据处理模块。当所述心排量数据处理模块的监测值未达到该参数的基线值时，则提示进入前负荷数据处理模块或后负荷数据处理模块；优选地，当所述前负荷数据处理模块或后负荷数据处理模块的监测值未达到该参数的基线值或者标量差值时，则提示进入收缩力数据模块；当达到该参数的基线值或者标量差值时，则提示进入管理模式。Preferably, when the monitoring value of the cardiac output data processing module reaches the baseline value of the parameter, it prompts to check the beat rate data processing module. When the monitoring value of the cardiac output data processing module does not reach the baseline value of the parameter, it prompts to enter the preload data processing module or afterload data processing module; preferably, when the preload data processing module or afterload When the monitoring value of the data processing module does not reach the baseline value or the scalar difference value of the parameter, it prompts to enter the contraction force data module; when it reaches the baseline value or the scalar difference value of the parameter, it prompts to enter the management mode.优选地，当各个血流动力学参数数据处理模块均完成判断，而判断依旧为“否”时，则提示观察肌肉组织氧数据处理模块。Preferably, when each hemodynamic parameter data processing module completes the judgment, and the judgment is still "No", then the muscle tissue oxygen data processing module is prompted to observe.
- 根据权利要求1-6任一项所述的围手术期用管理装置，其特征在于，所述各模块之间的连接为有线连接和/或无线连接；The perioperative management device according to any one of claims 1-6, wherein the connection between the modules is a wired connection and/or a wireless connection;优选地，所述显示模块包括提供显示界面的显示屏；优选地，显示屏为触摸式或非触摸式。Preferably, the display module includes a display screen providing a display interface; preferably, the display screen is touch-type or non-touch-type.优选地，所述显示模块还包括显示控制器，用于将控制输出的可视化图形、文字、图片等的显示和/或更新。Preferably, the display module further includes a display controller for displaying and/or updating control output visual graphics, text, pictures, etc.优选地，所述管理装置还包括中央处理器，作为数据处理及各模块的最终处理、执行单元。Preferably, the management device further includes a central processing unit as a data processing and final processing and execution unit of each module.优选地，所述管理装置还包括一个或多个存储器。优选地，各模块可分别置于不同的存储器中。优选由中央处理器运行或执行存储在存储器中的各个模块，以执行装置的各种功能和处理数据。Preferably, the management device further includes one or more memories. Preferably, each module can be respectively placed in different memories. The various modules stored in the memory are preferably run or executed by the central processing unit to perform various functions of the device and process data.优选地，所述管理装置还包括通讯模块，用于接受通讯信号并将其转化为电信号，以及将电信号转化为通讯信号后发送。Preferably, the management device further includes a communication module, configured to receive communication signals and convert them into electrical signals, and convert the electrical signals into communication signals before sending them.优选地，所述管理装置能够通过通讯模块与外部网络或其他设备进行通讯连接。Preferably, the management device can communicate with an external network or other devices through a communication module.优选地，所述管理装置还包括电源***，为装置中的各模块、元件或电路提供电力。Preferably, the management device further includes a power supply system to provide power for each module, element or circuit in the device.优选地，所述管理装置还包括外设接口，与中央处理器、信号采集器、通讯模块、显示控制器等分别连接。Preferably, the management device further includes a peripheral interface, which is respectively connected to the central processing unit, the signal collector, the communication module, the display controller and the like.
- 一种围手术期管理方法，其特征在于，所述方法包括如下步骤：A perioperative management method, characterized in that the method comprises the steps of:在手术前获取处于清醒状态的管理对象的肌肉组织氧(SmtO 2)、心排量(CO)和血压(BP)的基线测量值，以得到各监测指标的基线值； Obtain the baseline measurement values of muscle tissue oxygen (SmtO 2 ), cardiac output (CO) and blood pressure (BP) in awake subjects before the operation, so as to obtain the baseline values of each monitoring index;手术过程中监测肌肉SmtO 2监测值<70％(或者<75％)或低于其基线值(优选以二者数值中的较高者为准)，并持续时间≥60s时，则开始进行干预治疗，以使管理对象的心排量(CO)和血压(BP)维持在正常范围； During the operation, when the monitoring value of muscle SmtO 2 is <70% (or <75%) or lower than its baseline value (preferably whichever is higher in the two values), and the duration is ≥60s, the intervention is started Treatment to maintain the cardiac output (CO) and blood pressure (BP) of the managed subjects in the normal range;若干预治疗后，肌肉SmtO 2监测值仍未落入上述范围内时，则开始排查其他因素，针对排查得到的影响因素进行干预管理； If after the intervention treatment, the muscle SmtO 2 monitoring value still does not fall within the above range, start to check other factors, and carry out intervention management based on the influencing factors obtained from the check;当所有可能影响因素均排查完成后，肌肉SmtO 2监测值依旧未落入上述范围内，则考虑开启下一个循环管理。 When all possible influencing factors have been checked and the muscle SmtO 2 monitoring value still does not fall within the above range, consider starting the next cycle of management.
- 根据权利要求8所述的管理方法，其特征在于，所述管理方法使用权利要求1-7任一项所述管理装置进行。The management method according to claim 8, characterized in that the management method is performed using the management device described in any one of claims 1-7.
- 权利要求1-7任一项所述装置或权利要求8-9任一项所述方法在抑制和/或治疗围手术期并发症 中的应用；The application of the device according to any one of claims 1-7 or the method according to any one of claims 8-9 in suppression and/or treatment of perioperative complications;优选地，权利要求1-7任一项所述装置或权利要求8-9任一项所述方法在抑制和/或治疗围手术期并发症的***中的应用。Preferably, the application of the device according to any one of claims 1-7 or the method according to any one of claims 8-9 in a system for inhibiting and/or treating perioperative complications.优选地，权利要求1-7任一项所述装置在处理、管理或分析围手术期生理参数或生理数据(例如围手术期生理参数或生理数据)中的应用。Preferably, the application of the device according to any one of claims 1-7 in processing, managing or analyzing perioperative physiological parameters or physiological data (eg, perioperative physiological parameters or physiological data).优选地，权利要求1-7任一项所述装置在处理、管理或分析围手术期生理参数或生理数据(例如围手术期生理参数或生理数据)的***中的应用。Preferably, the application of the device according to any one of claims 1-7 in a system for processing, managing or analyzing perioperative physiological parameters or physiological data (eg, perioperative physiological parameters or physiological data).优选地，权利要求1-7任一项所述装置或权利要求8-9任一项所述方法在围手术期低血压诊断中的应用；Preferably, the application of the device according to any one of claims 1-7 or the method according to any one of claims 8-9 in the diagnosis of perioperative hypotension;优选地，权利要求1-7任一项所述装置或权利要求8-9任一项所述方法在促进术后恢复中的应用。Preferably, the application of the device according to any one of claims 1-7 or the method according to any one of claims 8-9 in promoting postoperative recovery.
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| CN202180101097.3A CN117979884A (en) | 2021-07-27 | 2021-07-27 | Perioperative management device and method based on muscle tissue oxygen monitoring and application thereof |
| TW111207607U TWM635975U (en) | 2021-07-27 | 2022-07-14 | Perioperative Management Device Based on Muscle Tissue Oxygen Monitoring |
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- 2021-07-27 CN CN202180101097.3A patent/CN117979884A/en active Pending
- 2021-07-27 WO PCT/CN2021/108718 patent/WO2023004588A1/en active Application Filing
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| US20060015025A1 (en) * | 2002-08-16 | 2006-01-19 | Johnstone Alan J | Method and apparatus for determining ischaemia |
| US20080208011A1 (en) * | 2007-02-27 | 2008-08-28 | Michael Simms Shuler | Method and System for Monitoring Oxygenation Levels of a Compartment for Detecting Conditions of a Compartment Syndrome |
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