Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography

Study Overview
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Brief Summary
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Physioflow® is a new device for measuring cardiac output in a non-invasive way using a thoracic bioimpedance technique. This technique has been validated in patients in stress tests as well as in Chronic Obstructive Pulmonary Disease (COPD) patients, in obese patients and in children. Very little work has been published in intensive care unit (ICU) and no studies have been done on hemodynamically unstable patients. The aim of this work is to compare the cardiac output measured by Physioflow® to the transthoracic echocardiography (TTE) in ventilated, sedated patients hospitalized in ICU receiving catecholamines and for whom the attending physician wants to evaluate the fluid responsiveness using the TTE and a passive leg raising maneuver (PLR).

Detailed Description
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All patients included will be simultaneously monitored with TTE and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after PLR. If the attending physician decide to administer fluid expansion a new set of cardiac output measurement will be performed before and after the volume expansion.

Official Title
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Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography

Conditions
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Cardiac Output

Intervention / Treatment
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* Procedure: cardiac output measure with TTE
* Procedure: cardiac output measure with Physioflow® thoracic electrical bioimpedance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient more than 18 year-old patient sedated and adapted to the assisted controlled ventilation patient receiving catecholamine (norepinephrine, epinephrine or dobutamine) patient requiring an haemodynamic evaluation by trans-thoracic echocardiography and PLR according to the attending physician Exclusion Criteria: pregnant women patients with a poor echogenicity patients deprived of public law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cardiac output measure with TTE|All patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR)|
|Procedure: cardiac output measure with Physioflow® thoracic electrical bioimpedance|All patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of cardiac output with transthoracic echocardiography (TTE) before PLR | Measure of Cardiac output with transthoracic echocardiography (TTE) before passive leg raising maneuver (PLR) | during one hour , the day of inclusion | 
| Measure of Cardiac output with Physioflow before PLR | Measure of Cardiac output with Physioflow before passive leg raising maneuver (PLR) | during one hour , the day of inclusion | 
| Measure of cardiac output with transthoracic echocardiography (TTE) after PLR | Measure of cardiac output with transthoracic echocardiography (TTE) after passive leg raising maneuver (PLR) | during one hour , the day of inclusion | 
| Measure of cardiac output with Physioflow after PLR | Measure of cardiac output with Physioflow after passive leg raising maneuver (PLR) | during one hour , the day of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion | Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion | during one hour , the day of inclusion | 
| Measure of cardiac output with Physioflow after volume expansion | Measure of cardiac output with Physioflow after volume expansion | during one hour , the day of inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac output, trans thoracic echocardiography, passive leg raising, volume expansion