Skip to main content
MedPathMedPath Home
Clinical Trials/NCT05741918
NCT05741918
Recruiting
Not Applicable

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

University Hospital, Montpellier1 site in 1 country20 target enrollmentAugust 20, 2023
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsIntensive Care Units, Pediatric

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Units, Pediatric
Sponsor
University Hospital, Montpellier
Enrollment
20
Locations
1
Primary Endpoint
Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2023
End Date
September 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Adverse events on the day of catheter removal(Up to 21 days)
  • Variations of cardiac output before and after Leg Raise Test(Up to day 3)
  • Adverse events on the day of catheterization(Up to 21 days)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)Intensive Care
NCT01613859Transonic Systems Inc.9
Completed
Not Applicable
Comparison of Cardiac Output With LiDCO Rapid and TEE Against Thermodilution Technique in Cardiac SurgeryLow Cardiac Output
NCT02511457University of Iowa110
Terminated
Not Applicable
Cardiac Output Measurement at the Conclusion of Cardiopulmonary BypassCardiac Output
NCT01103908Transonic Systems Inc.3
Completed
Not Applicable
Cardiac Output Monitoring by Transpulmonary Thermodilution and Transthoracic Echocardiography in Critically Ill PatientsSinus Rhythm
NCT04637126University Hospital, Toulouse36
Completed
Not Applicable
Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution TechniqueCardiac DiseasePost Surgery Patients
NCT01616017Transonic Systems Inc.39