Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT03937102
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2019-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reacshock
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: