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

Intensive Care Units, Pediatric Clinical Trial

— PEDIA-FICK-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741918
• Other study ID #: RECHMPL22_0227
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: University Hospital, Montpellier
• Contact: Arthur GAVOTTO, PH-U
• Phone: +334.67.33.66.09
• Email: a-gavotto[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Units, Pediatric

Intervention

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

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Variations of cardiac output before and after Leg Raise Test		Up to day 3
Secondary	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
Secondary	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