Clinical Trials Directory

Trials / Completed

CompletedNCT03937102

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

Status
Completed
Phase
Study type
Observational
Enrollment
1 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcardiac output measure with TTEAll 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)
PROCEDUREcardiac output measure with Physioflow® thoracic electrical bioimpedanceAll 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)

Timeline

Start date
2019-04-25
Primary completion
2020-04-01
Completion
2020-04-01
First posted
2019-05-03
Last updated
2023-03-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03937102. Inclusion in this directory is not an endorsement.