Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937102
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Centre Hospitalier de Lens
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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).

Condition or disease Intervention/treatment
Cardiac Output Procedure: cardiac output measure with TTE Procedure: cardiac output measure with Physioflow® thoracic electrical bioimpedance

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Intervention Details:
  • 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)
  • Procedure: 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)


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937102


Contacts
Layout table for location contacts
Contact: Julien Maizel, Pr (33)322087807 maizel.julien@chu-amiens.fr

Locations
Layout table for location information
France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Julien Maizel, Pr    (33)322087807    maizel.julien@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier de Lens
Investigators
Layout table for investigator information
Principal Investigator: Didier Thevenin, MD Centre Hospitalier de Lens
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03937102    
Other Study ID Numbers: PI2018_843_0001
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
cardiac output
trans thoracic echocardiography
passive leg raising
volume expansion