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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03937102
• Collaborator: Centre Hospitalier de Lens (Other)
• Enrollment: 95
• Location: 1
• Anticipated Duration (Months): 11.2
• Patients Per Site Per Month: 8.5

Study Details

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	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated 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: Apr 25, 2019
• Anticipated Primary Completion Date: Apr 1, 2020
• Anticipated Study Completion Date: Apr 1, 2020

Outcome Measures

Primary Outcome Measures

1. Measure of cardiac output with transthoracic echocardiography (TTE) before PLR [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 [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 [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 [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 [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 [during one hour , the day of inclusion]

   Measure of cardiac output with Physioflow after volume expansion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens
• Centre Hospitalier de Lens

Investigators

• Principal Investigator: Didier Thevenin, MD, Centre Hospitalier de Lens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03937102
• Other Study ID Numbers: PI2018_843_0001
• First Posted: May 3, 2019
• Last Update Posted: May 3, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of May 3, 2019