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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05741918
Collaborator
(none)
20
Enrollment
1
Arm
14.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Fick's method
  • Diagnostic Test: Echocardiography
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) : Prospective Feasibility Study
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pediatric Intensive Care Units Patients

Patients under 18 admitted in pediatric intensive care unit

Diagnostic Test: Fick's method
Cardiac output measurement by Fick method

Diagnostic Test: Echocardiography
Cardiac output measurement by echocardiography

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Variations of cardiac output before and after Leg Raise Test [Up to day 3]

  2. Adverse events on the day of catheterization [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
28 Days to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT05741918
Other Study ID Numbers:
  • RECHMPL22_0227
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Cardiac output
Oxygen Consumption (VO2)
Fick
Pediatric Intensive Care Unit

Study Results

No Results Posted as of Feb 27, 2023