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

NCT ID: NCT03937102

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-25

Study Completion Date

2020-04-01

Brief Summary

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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

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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.

Conditions

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Cardiac Output

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Lens

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier Thevenin, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Lens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2018_843_0001

Identifier Type: -

Identifier Source: org_study_id

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