Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05741918

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intensive Care Units, Pediatric

Age range

28 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Montpellier

Montpellier, France

Location status: Recruiting

Location contact

Arthur GAVOTTO, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fick's method

Diagnostic Test

Cardiac output measurement by Fick method

Echocardiography

Diagnostic Test

Cardiac output measurement by echocardiography

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

    Time frame: Up to 21 days

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

  3. Adverse events on the day of catheter removal

    Time frame: Up to 21 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur GAVOTTO, PH-U

CONTACT

[email protected]

+334.67.33.66.09

Gilles CAMBONIE, Pr

CONTACT

[email protected]

+334.67.33.65.56

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: PEDIA-FICK-ICU

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2023
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.