Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) (PEDIA-FICK-ICU)

NCT ID: NCT05741918

Last Updated: 2024-08-26

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

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2025-09-30

Brief Summary

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Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring.

The goal of this clinical trial is to evaluate the feasibility of cardiac output measurement by Fick's method, non-invasive and allowing continuous monitoring, in comparison to echocardiography in pediatric intensive care unit.

Detailed Description

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Conditions

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Intensive Care Units, Pediatric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pediatric Intensive Care Units Patients

Patients under 18 admitted in pediatric intensive care unit

Group Type EXPERIMENTAL

Fick's method

Intervention Type DIAGNOSTIC_TEST

Cardiac output measurement by Fick method

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Cardiac output measurement by echocardiography

Interventions

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Fick's method

Cardiac output measurement by Fick method

Intervention Type DIAGNOSTIC_TEST

Echocardiography

Cardiac output measurement by echocardiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient under 18 years old
* Patient over 10 kg
* Patient requiring intubation or intubated with a cuffed tube
* Patient requiring a central venous line in superior vena cava territory

Exclusion Criteria

* Mechanical ventilation with leak
* Bad echogenicity preventing echocardiography
* Absence of written informed consent
* Patient not affiliated to French Health Insurance or not covered by public health insurance
* Patient with a legal protection
Minimum Eligible Age

28 Days

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UH Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Arthur GAVOTTO, PH-U

Role: CONTACT

+334.67.33.66.09

Gilles CAMBONIE, Pr

Role: CONTACT

+334.67.33.65.56

Facility Contacts

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Arthur GAVOTTO, MD

Role: primary

Other Identifiers

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RECHMPL22_0227

Identifier Type: -

Identifier Source: org_study_id

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