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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-17
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Fick's method

    Diagnostic test

    Cardiac output measurement by Fick method

  • Echocardiography

    Diagnostic test

    Cardiac output measurement by echocardiography

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Pediatric Intensive Care Units PatientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

Variations of cardiac output before and after Leg Raise Test

Time frame
Up to day 3
2

Adverse events on the day of catheterization

Complications possibly due to Fick's method on the day of catheterization : pneumothorax, bleeding, rhythm disorder, gas embolism, failure to place, other

Time frame
Up to 21 days
3

Adverse events on the day of catheter removal

Complications possibly due to Fick's method on the day of catheter removal : catheter thrombosis, catheter infection, non-functional oximetry catheter

Time frame
Up to 21 days

Other outcomes

Sponsors and contacts

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