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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05741918
Acronym
PEDIA-FICK-ICU
Enrollment
20
Registered
2023-02-23
Start date
2023-08-20
Completion date
2025-09-30
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Units, Pediatric

Keywords

Cardiac output, Oxygen Consumption (VO2), Fick, Pediatric Intensive Care Unit

Brief 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.

Interventions

DIAGNOSTIC_TESTFick's method

Cardiac output measurement by Fick method

DIAGNOSTIC_TESTEchocardiography

Cardiac output measurement by echocardiography

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Days to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiographyUp to day 3

Secondary

MeasureTime frameDescription
Variations of cardiac output before and after Leg Raise TestUp to day 3
Adverse events on the day of catheterizationUp to 21 daysComplications possibly due to Fick's method on the day of catheterization : pneumothorax, bleeding, rhythm disorder, gas embolism, failure to place, other
Adverse events on the day of catheter removalUp to 21 daysComplications possibly due to Fick's method on the day of catheter removal : catheter thrombosis, catheter infection, non-functional oximetry catheter

Countries

France

Contacts

Primary ContactArthur GAVOTTO, PH-U
a-gavotto@chu-montpellier.fr+334.67.33.66.09
Backup ContactGilles CAMBONIE, Pr
g-cambonie@chu-montpellier.fr+334.67.33.65.56

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026