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

Not Applicable

Recruiting

• Conditions: Intensive Care Units, Pediatric
• Interventions: Diagnostic Test: Fick's method; Diagnostic Test: Echocardiography

• Registration Number: NCT05741918
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-23
• Study Start: 2023-08-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric Intensive Care Units Patients	Echocardiography	Patients under 18 admitted in pediatric intensive care unit
Pediatric Intensive Care Units Patients	Fick's method	Patients under 18 admitted in pediatric intensive care unit

Primary Outcome Measures

Name	Time	Method
Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography	Up to day 3

Secondary Outcome Measures

Name	Time	Method
Variations of cardiac output before and after Leg Raise Test	Up to day 3
Adverse events on the day of catheterization	Up to 21 days	Complications possibly due to Fick's method on the day of catheterization : pneumothorax, bleeding, rhythm disorder, gas embolism, failure to place, other
Adverse events on the day of catheter removal	Up to 21 days	Complications possibly due to Fick's method on the day of catheter removal : catheter thrombosis, catheter infection, non-functional oximetry catheter

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France