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

NCT03937102 | Completed

• 1 other identifier: PI2018_843_0001
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Output

Keywords

cardiac output; trans thoracic echocardiography; passive leg raising; volume expansion

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

  during one hour , the day of inclusion

Interventions

cardiac output measure with TTE PROCEDURE

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 PROCEDURE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• pregnant women
• patients with a poor echogenicity
• patients deprived of public law

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Centre Hospitalier de Lens: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Study Officials

• Didier Thevenin, MD

  Centre Hospitalier de Lens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 3, 2019
• Study Start: April 25, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)