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Clinical Trials/NCT03937102
NCT03937102
Completed
Not Applicable

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

Centre Hospitalier Universitaire, Amiens1 site in 1 country1 target enrollmentApril 25, 2019
ConditionsCardiac Output

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Output
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
1
Locations
1
Primary Endpoint
Measure of cardiac output with transthoracic echocardiography (TTE) before PLR
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 25, 2019
End Date
April 1, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Measure of cardiac output with transthoracic echocardiography (TTE) before PLR

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: during one hour , the day of inclusion

Measure of cardiac output with Physioflow after passive leg raising maneuver (PLR)

Secondary Outcomes

  • 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)

Study Sites (1)

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