Clinical trial NCT03937102: Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography
Official title: Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Keywords: cardiac output
trans thoracic echocardiography
passive leg raising
volume expansion
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Lens
First posted: 2019-05-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Measure of cardiac output with transthoracic echocardiography (TTE) before PLR
timeFrame: during one hour , the day of inclusion
measure: Measure of Cardiac output with Physioflow before PLR
timeFrame: during one hour , the day of inclusion
measure: Measure of cardiac output with transthoracic echocardiography (TTE) after PLR
timeFrame: during one hour , the day of inclusion
measure: Measure of cardiac output with Physioflow after PLR
timeFrame: during one hour , the day of inclusion
Secondary outcomes:
measure: Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion
timeFrame: during one hour , the day of inclusion
measure: Measure of cardiac output with Physioflow after volume expansion
timeFrame: during one hour , the day of inclusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: Centre Hospitalier de Lens
name: Didier Thevenin, MD
role: PRINCIPAL_INVESTIGATOR
References: