NCT05741918

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

August 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

February 13, 2023

Last Update Submit

August 23, 2024

Conditions

Intensive Care Units, Pediatric

Keywords

Cardiac outputOxygen Consumption (VO2)FickPediatric Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Adverse events on the day of catheter removal

    Up to 21 days

Study Arms (1)

Pediatric Intensive Care Units Patients

EXPERIMENTAL

Patients under 18 admitted in pediatric intensive care unit

Diagnostic Test: Fick's methodDiagnostic Test: Echocardiography

Interventions

Fick's methodDIAGNOSTIC_TEST

Cardiac output measurement by Fick method

Pediatric Intensive Care Units Patients
EchocardiographyDIAGNOSTIC_TEST

Cardiac output measurement by echocardiography

Pediatric Intensive Care Units Patients

Eligibility Criteria

Age28 Days - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Arthur GAVOTTO, PH-U

CONTACT

+334.67.33.66.09a-gavotto@chu-montpellier.fr

Gilles CAMBONIE, Pr

CONTACT

+334.67.33.65.56g-cambonie@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 23, 2023

Study Start

August 20, 2023

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)