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

Cardiac Output Clinical Trial

— Reacshock  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937102
• Other study ID #: PI2018_843_0001
• Status: Completed
• Start date: April 25, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output

Intervention

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)
• 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)

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier de Lens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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