WO2014166504A1 - Procédé et dispositif visant à prédire la sensibilité fluidique de patients - Google Patents

Procédé et dispositif visant à prédire la sensibilité fluidique de patients Download PDF

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Publication number
WO2014166504A1
WO2014166504A1 PCT/DK2014/050094 DK2014050094W WO2014166504A1 WO 2014166504 A1 WO2014166504 A1 WO 2014166504A1 DK 2014050094 W DK2014050094 W DK 2014050094W WO 2014166504 A1 WO2014166504 A1 WO 2014166504A1
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WO
WIPO (PCT)
Prior art keywords
measure
cardiac
input data
subject
processor
Prior art date
Application number
PCT/DK2014/050094
Other languages
English (en)
Inventor
Simon Tilma VISTISEN
Original Assignee
Aarhus Universitet
Region Midtjylland
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aarhus Universitet, Region Midtjylland filed Critical Aarhus Universitet
Publication of WO2014166504A1 publication Critical patent/WO2014166504A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/364—Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/029—Measuring or recording blood output from the heart, e.g. minute volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A61M2230/06—Heartbeat rate only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/30—Blood pressure

Definitions

  • the invention relates to the field of medical devices. More specifically, the invention provides a software method and a device for predicting fluid
  • Reliable fluid responsiveness monitoring has been sought for decades.
  • a patient group specifically in need of reliable fluid responsiveness prediction monitoring is septic patients. In Denmark, 12,000 patients develop sepsis, and they
  • CVP central venous pressure
  • PPV pulse pressure variation
  • Dynamic variables are today mainly useful in the operating rooms, in the first few post-operative hours following major surgery and in the initial hours after intubation of critically ill patients. Consequently, no reliable continuous monitoring technique exists for most critically ill patients, and it has never existed for spontaneously breathing patients.
  • the invention provides a fluid responsiveness prediction system arranged to predict fluid responsiveness of a subject, wherein the system comprises
  • - input means e.g. an input unit
  • a processor arranged to control the processing unit.
  • a measure of cardiac beat performance such as to calculate a change in a measure of cardiac beat performance, in relation to the identified extra systole, in accordance with the input data
  • the invention is based in the insight that (spontaneous) extra systoles, which most people experience frequently, induce a convenient intermittent physiologic preload change, which can be used to extract a measure that allow prediction of fluid responsiveness of a subject.
  • extra systoles introduce a cardiac preload change, which can be used to derive a measure of a change in cardiac beat performance, e.g. change in pre-ejection period ( ⁇ ) or systolic blood pressure (ASBP).
  • ⁇ pre-ejection period
  • ASBP systolic blood pressure
  • the proposed system is convienient for use in (but not limited to) patients seen in emergency departments and intensive care units (ICUs) , since the data indicative of cardiac beat performance is normally available in the form of Electro Cardio Graphy (ECG) data, and e.g. pulseoximetry and/or continuous blood pressure data.
  • ECG Electro Cardio Graphy
  • pulseoximetry and/or continuous blood pressure data e.g. pulseoximetry and/or continuous blood pressure data.
  • ECG is the preferred signal from which to detect the occurrence of an extra systole.
  • the input means can receive - first input data indicative of an ECG obtained from a subject, and to receive
  • the indication of predicted fluid responsiveness may be generated by comparing cardiac beat performance at the post ectopic beat with cardiac beat performance at a number of preceeding and/or following sinus beats.
  • the input data comprises data indicative of induced changes in a cardiac preload dependent hemodynamic variable.
  • the input data comprises data indicative of a hemodynamic variable estimating cardiac beat performance on a heart beat to heart beat basis in relation to baseline heart beats preceeding or following at least one of: an ectopic beat, a post-ectopic beat, and a heart beat immediately following a post- ectopic beat.
  • a change in cardiac beat performance in response to the extra systole may be derived. E.g. by calculating a change from a baseline cardiac beat performance to a cardiac beat performance in response to the extra systole's post ectopic beat.
  • a baseline cardiac beat performance may be calculated as an average or other statistical measure of heart beat to heart beat performance for a number, e.g. 5-10 normal (sinus) heart beats, preceding and/or following an extra systole.
  • the input data comprises data indicative of at least one of cardiac beat performance variables.
  • cardiac beat performance could be, but is not limited to: a systolic arterial blood pressure, an arterial pulse pressure, a time derivative of arterial pressure upstroke (dP/dt), a pre-ejection period (PEP), a measure of cardiac stroke volume, a hemodynamic characteristics of the plethysmographic curve, a measure of cardiac stroke work, and a measure of blood flow.
  • dP/dt time derivative of arterial pressure upstroke
  • PEP pre-ejection period
  • a measure of cardiac stroke volume a hemodynamic characteristics of the plethysmographic curve
  • a measure of cardiac stroke work a measure of cardiac stroke work
  • a measure of blood flow a measure of blood flow.
  • the input data may comprise a direct or indirect hemodynamic characteristic derived from a sensor capable of performing measuring a
  • the input means may be arranged to receive data from a
  • the processor is arranged to calculate a measure of change in pre-ejection period ( ⁇ ) or systolic arterial blood pressure (ASBP) in relation to the identified extra systole.
  • ⁇ and ASBP have been verified in animal experiments and in an observational clinical setting to provide a reliable measure of fluid responsiveness when induced by an extra systole.
  • ⁇ or ASBP may be calculated as a difference between a measure of baseline PEP or SBP and a measure of PEP or SBP determined in response to the identified extra systole's post ectopic beat.
  • the processor may then compare the calculated ⁇ or ASBP with a predetermined reference value, and to generate the indication of predicted fluid responsiveness of the subject accordingly.
  • One system embodiment comprises an ECG device arranged to obtain ECG data on the subject.
  • the processor may be housed within said ECG device.
  • Such embodiment can be based on an existing ECG device, where the processor according to the invention is the processor available in existing equipment, which is programmed to perform according to this invention.
  • the system may comprise e.g. a blood pressure measurement device or another device from which it is possible to extract cardiac beat performance variables from a subject.
  • the computer program product may cause the processor to update a fluid responsiveness prediction in response to data from the patient continuously, e.g. outputting a prediction result estimate using a number and/or text and/or a grapic symbol on a display, and/or using an audible output.
  • the fluid responsiveness prediction result may be updated each time a new extra systole is identified, thus creating new data for a prediction calculation.
  • FIG. 1 illustrates a block diagram of basic parts of a system embodiment with a processor or processor system P arranged to receive two input data streams: Electro Cardio Graphy data ECG, as well as data indicative of a hemodynamic variable HV, e.g. data from an oximetry or arterial blood pressure device.
  • ECG Electro Cardio Graphy data
  • HV hemodynamic variable
  • An arterial catheter was placed through a sheet in a femoral artery and used for arterial blood sampling as well as continuous monitoring of arterial pressure (AP).
  • a pulse oximeter was placed and securely fixed on the animal's tale.
  • Three lead ECG was monitored. ECG (lead II), AP, and plethysmographic curves were continuously sampled at 300 Hz throughout the experiment and continuous CO, HR and mean arterial pressure (MAP) was sampled every minute by monitor dedicated software (S/5 Collect, General Electric, Datex-Ohmeda Division, Instrumentarium Corp., UK).
  • the main experiment began with a basic data registration. After that, the pacing protocol was executed (see below) and then, four intravascular volume shifts were performed, of which each was followed by the pacing protocol. The first was a controlled bleeding of 25% estimated blood volume (660 ml for all pigs) performed during 15-20 minutes (hypovolemia). The blood was bleed into a bag with anticoagulants and saved for the second volume shift, retransfusion. In an attempt to reach a more clinically relevant level after retransfusion, we transfused 500 ml blood (19% of estimated blood volume) because pigs autotransfuse from the spleen following bloodletting.
  • Fluid responsiveness was defined as an increase in SV of 15% or more following volume expansion.
  • Fig. 5 shows the corresponding ROC curve presenting an area under the ROC curve of 0.84.
  • the optimal 6 ms threshold corresponded to a sensitivity of 71% and specificity of 77% .
  • Sensitivity and specificity values of the variables in Table 1 from both atrial as well as ventricular extra systoles are seen in Table 4, which shows that PEB characteristics from ventricular extra systoles were generally superior to those from atrial extra systoles in predicting fluid responsiveness.
  • Classification characteristics for CVP were: Area under ROC curve: 0.89, sensitivity of 100%, specificity of 65% at a threshold of 4.5 mmHg.
  • Classification characteristics for PAOP were: Area under ROC curve: 0.90, sensitivity of 100%, specificity of 65% at a threshold of 7.5 mmHg.
  • Optimal thresholds, sensitivities, and specificities are reported for ventricular extra systoles with areas under the ROC curve (AUCs) above 0.65.
  • CABG coronary artery bypass grafting
  • the ASBP variable appears very interesting in the clinical setting of the investigating patient group (post-cardiac suregery patients).
  • atrial extra systoles are more prevalent than ventricular extra systoles.
  • the ASBP "sibling" variable that can be detected from the plethysmographic curve was not as interesting as the ASBP variable derived from the arterial blood pressure signal, e.g. partly because only 13 data points were available for this recording.
  • FIG. 6 illustrates a method embodiment according to the invention.
  • the method comprises receiving ECG data R_ECG, e.g. from an ECG device, and receiving data indicative of a blood pressure curve R_BPC, e.g. from a pulseoximetry device.
  • E.g. 5-10 baseline heart beats can be used to calculate a baseline cardiac beat performance comprising calculating e.g. a baseline Pre-Ejection Period (PEP), C_BPEP.
  • PEP Pre-Ejection Period
  • the method can be performed on a stored data set, or it can be implemented so as to real-time monitor a patient where ECG and pulseoximetry data are continuously received at a pre-defined sample rate.
  • PEP Pre-Ejection Period

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pulmonology (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

L'invention porte sur un dispositif et un procédé destinés à prédire la sensibilité fluidique d'un sujet, par exemple d'un patient atteint de septicémie. Des données d'entrée indiquant les performances du sujet en matière de rythme cardiaque, par exemple un ECG, et/ou des données indiquant une variable hémodynamique dépendante de la pré-charge, sont employées pour identifier des extrasystoles spontanées. On calcule une mesure des performances en termes de rythme cardiaque, par exemple une modification de la période de pré-éjection (PEP) ou de la pression sanguine systolique (SBP) en réponse à l'extrasystole par rapport à une PEP de ligne de base, en lien avec l'extrasystole identifiée. En réponse à quoi, une indication de la sensibilité fluidique prévue pour le sujet est générée. L'invention concerne en outre la prédiction fiable de la sensibilité fluidique à partir des données fournies par les équipements de monitorage existants employés dans les unités de soins intensifs.
PCT/DK2014/050094 2013-04-11 2014-04-11 Procédé et dispositif visant à prédire la sensibilité fluidique de patients WO2014166504A1 (fr)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108937881A (zh) * 2017-05-23 2018-12-07 深圳市理邦精密仪器股份有限公司 确定对象容量反应性的方法和设备
US10328202B2 (en) 2015-02-04 2019-06-25 Covidien Lp Methods and systems for determining fluid administration
US10499835B2 (en) 2015-03-24 2019-12-10 Covidien Lp Methods and systems for determining fluid responsiveness in the presence of noise

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040186525A1 (en) * 2003-03-20 2004-09-23 Burnes John E. Method and apparatus for gauging cardiac status using post premature heart rate turbulence
EP1813187A1 (fr) * 2006-01-31 2007-08-01 UP Management GmbH & Co Med-Systems KG Appareil pour évaluer l'état hémodynamique d'un patient en utilisant l'interaction coeur-poumon
WO2009023713A2 (fr) * 2007-08-13 2009-02-19 Edwards Lifesciences Corporation Évaluation d'une dépendance à une précharge et d'une réactivité à un fluide

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040186525A1 (en) * 2003-03-20 2004-09-23 Burnes John E. Method and apparatus for gauging cardiac status using post premature heart rate turbulence
EP1813187A1 (fr) * 2006-01-31 2007-08-01 UP Management GmbH & Co Med-Systems KG Appareil pour évaluer l'état hémodynamique d'un patient en utilisant l'interaction coeur-poumon
WO2009023713A2 (fr) * 2007-08-13 2009-02-19 Edwards Lifesciences Corporation Évaluation d'une dépendance à une précharge et d'une réactivité à un fluide

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
S. T. VISTISEN ET AL.: "Automated pre-ejection period variation indexed to tidal volume predicts fluid responsiveness after cardiac surgery", ACTA ANAESTHESIOL. SCAND., vol. 53, 2009, pages 534 - 542
SALVATORE PALA ET AL: "Comparisons of predictors of fluid responsiveness in major surgery", THE EFFECT OF APPLIED COMPRESSIVE LOADING ON TISSUE-ENGINEERED CARTILAGE CONSTRUCTS CULTURED WITH TGF-BETA3, IEEE, 28 August 2012 (2012-08-28), pages 3128 - 3130, XP032463602, ISSN: 1557-170X, DOI: 10.1109/EMBC.2012.6346627 *
VISTISEN ST; KOEFOED-NIELSEN J; LARSSON A: "Automated pre-ejection period variation predicts fluid responsiveness in low tidal volume ventilated pigs", ACTA ANAESTHESIOL SCAND, vol. 54, 2010, pages 199 - 205

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10328202B2 (en) 2015-02-04 2019-06-25 Covidien Lp Methods and systems for determining fluid administration
US11975175B2 (en) 2015-02-04 2024-05-07 Covidien Lp Methods and systems for determining fluid administration
US10499835B2 (en) 2015-03-24 2019-12-10 Covidien Lp Methods and systems for determining fluid responsiveness in the presence of noise
CN108937881A (zh) * 2017-05-23 2018-12-07 深圳市理邦精密仪器股份有限公司 确定对象容量反应性的方法和设备
CN108937881B (zh) * 2017-05-23 2021-08-10 深圳市理邦精密仪器股份有限公司 确定对象容量反应性的方法和设备

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