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Completed

NCT Number: NCT03937102

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

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).

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Key information

Conditions

Cardiac Output

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80480, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  1. Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion

    Time frame: during one hour , the day of inclusion

    Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion

  2. Measure of cardiac output with Physioflow after volume expansion

    Time frame: during one hour , the day of inclusion

    Measure of cardiac output with Physioflow after volume expansion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Hospitalier de Lens

Registry information

Acronym: Reacshock

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 3, 2019
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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