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

Study Overview
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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.

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

Conditions
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Intensive Care Units, Pediatric

Intervention / Treatment
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* Diagnostic Test: Fick's method
* Diagnostic Test: Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient under 18 years old Patient over 15 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

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric Intensive Care Units Patients<br>Patients under 18 admitted in pediatric intensive care unit | Diagnostic Test: Fick's method<br>* Cardiac output measurement by Fick method<br>Diagnostic Test: Echocardiography<br>* Cardiac output measurement by echocardiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variations of cardiac output before and after Leg Raise Test |  | Up to day 3 | 
| 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 | Up to 21 days | 
| 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 | Up to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac output, Oxygen Consumption (VO2), Fick, Pediatric Intensive Care Unit