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Recruiting NCT05741918

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

No phase Interventional Intensive Care Units, Pediatric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fick's method, Echocardiography.
Who it may be relevant to
Registry conditions: Intensive Care Units, Pediatric. Basic parameters: 28 Days — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test Fick's method
    Cardiac output measurement by Fick method
  • Diagnostic test Echocardiography
    Cardiac output measurement by echocardiography

Primary outcome measures

  • Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography [Time frame: Up to day 3]
Secondary outcome measures (3)
  • Variations of cardiac output before and after Leg Raise Test [Time frame: Up to day 3]
  • Adverse events on the day of catheterization [Time frame: Up to 21 days]
  • Adverse events on the day of catheter removal [Time frame: Up to 21 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • UH Montpellier — Montpellier

Identifiers

NCT: NCT05741918 · RECHMPL22_0227

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗