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

Completed

• Conditions: Cardiac Output

• Registration Number: NCT03937102
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-25
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of cardiac output with transthoracic echocardiography (TTE) before PLR	during one hour , the day of inclusion	Measure of Cardiac output with transthoracic echocardiography (TTE) before passive leg raising maneuver (PLR)
Measure of Cardiac output with Physioflow before PLR	during one hour , the day of inclusion	Measure of Cardiac output with Physioflow before passive leg raising maneuver (PLR)
Measure of cardiac output with transthoracic echocardiography (TTE) after PLR	during one hour , the day of inclusion	Measure of cardiac output with transthoracic echocardiography (TTE) after passive leg raising maneuver (PLR)
Measure of cardiac output with Physioflow after PLR	during one hour , the day of inclusion	Measure of cardiac output with Physioflow after passive leg raising maneuver (PLR)

Secondary Outcome Measures

Name	Time	Method
Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion	during one hour , the day of inclusion	Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion
Measure of cardiac output with Physioflow after volume expansion	during one hour , the day of inclusion	Measure of cardiac output with Physioflow after volume expansion

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France