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

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).

Study Overview

• Status: Completed
• Conditions: Cardiac Output
• Intervention / Treatment: Procedure: cardiac output measure with TTE; Procedure: cardiac output measure with Physioflow® thoracic electrical bioimpedance

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient ≥18 year-old, sedated and adapted to the assisted controlled ventilation, receiving catecholamine (norepinephrine, epinephrine or dobutamine), requiring an haemodynamic evaluation by trans-thoracic echocardiography and PLR according to the attending physician.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Centre Hospitalier de Lens
• Investigators: Principal Investigator: Didier Thevenin, MD, Centre Hospitalier de LENS

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cardiac output; volume expansion; passive leg raising; trans thoracic echocardiography
• Other Study ID Numbers: PI2018_843_0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No