Actively Recruiting

Phase Not Applicable
Age: 28Days - 17Years
All Genders
ID05741918

Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) : Prospective Feasibility Study

Led by University Hospital, Montpellier · Updated on 2024-08-26

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cardiac output measurement is an important hemodynamic parameter frequently used in pediatric intensive care units (ICUs). This trial aims to evaluate the feasibility of measuring cardiac output using Fick's method, a non-invasive technique that allows continuous monitoring, compared to the standard echocardiography method which is operator-dependent and cannot provide continuous data. The study is sponsored by University Hospital, Montpellier, and focuses on pediatric ICU patients under 18 years old. The study involves two diagnostic tests: cardiac output measurement by Fick's method using a metabolic monitor and measurement by echocardiography. Patients under 18 admitted to the pediatric ICU who meet specific criteria will be monitored using both methods. This comparison will assess the correlation between the two measures up to day 3 of monitoring. Participants will be monitored for cardiac output variations before and after a Leg Raise Test, and adverse events will be recorded on catheterization and catheter removal days, up to 21 days. The primary outcome is the agreement between cardiac output measurements by both methods within the first three days. The total participation involves close monitoring and safety assessments during their ICU stay until study completion in 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 28Days - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 3 days

Participants undergo cardiac output measurement by Fick method and echocardiography.

1 to 3 visits (in-person) depending on clinical condition

Trial Site Locations

Total: 1 location

1

UH Montpellier

Montpellier, France

Actively Recruiting

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Research Team

A

Arthur GAVOTTO, PH-U

G

Gilles CAMBONIE, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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