About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03937102

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted May 3, 2019

Study Description

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:Cardiac Output
  • Intervention/Treatment: Procedure: cardiac output measure with TTE
    Procedure: cardiac output measure with Physioflow® thoracic electrical bioimpedance
  • Phase: N/A
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.

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 95 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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 2019
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: April 2020
Outcome Measures
  • Primary Outcome Measures: 1. 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)
  • 2. 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)
  • 3. 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)
  • 4. 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)
  • 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
Eligibility Criteria
  • 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

Contacts and Locations
Contacts

Contact: Julien Maizel, Pr (33)322087807 maizel.julien@chu-amiens.fr

Locations

France
CHU Amiens
Amiens

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Centre Hospitalier de Lens

Investigators

Principal Investigator: Didier Thevenin, MD Centre Hospitalier de Lens

More Information
  • Responsible Party: Centre Hospitalier Universitaire, Amiens
  • ClinicalTrials.gov Identifier: NCT03937102 History of Changes
  • 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
  • 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