Validation of CardioQ Versus PiCCO in Children (CQPiCCO)

April 14, 2023 updated by: Radboud University Medical Center

Validation of an Ultrasound Oesophageal Doppler Cardiac Output Monitor (ODM+, CardioQ) Versus a Transpulmonary Thermodilution Cardiac Output Monitor (TPTD, PiCCO)

To compare the less invasive Oesophageal Doppler cardiac output Monitor (ODM) to the invasive (standard of care) Transpulmonary Thermodilution cardiac output monitor (TPTD) in children.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a validation study. The study period starts as soon as CMO approval is acquired and will end after inclusion of 17 patients. This study is designed to test the effectiveness of a non invasive ODM catheter compared to the invasive, gold standard, TPTD technique.

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Recruiting
        • Radboud Univeristy Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • GertJan Scheffer, prof. dr.
        • Sub-Investigator:
          • Anneliese Nusmeier, dr
        • Sub-Investigator:
          • Cor Slagt, dr
        • Sub-Investigator:
          • Joris Lemson, dr
        • Principal Investigator:
          • Marieke Voet, dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 0 to 16 years with an indication for invasive CO monitoring (TPTD). Indication for invasive CO monitoring always implies intubation and sedation.
  • Signed informed consent

Exclusion Criteria:

  • Congenital or acquired cardiovascular diseases (intracardiac/extracardiac intrathoracic shunt
  • Cardiac valve diseases
  • Aortic arch anomalies
  • Tissue necrosis of oesophagus
  • Carcinoma of pharynx, larynx of oesophagus
  • Severe bleeding diatheses
  • Age > 16 years
  • Weight < 3.5 kg or > 50 kg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CardioQ
CardioQ will be used as CO monitor simultaneously with the standard of care PiCCO CO monitor
Device: CardioQ
comparison of cardiac output measurements between gold standard transpulmonary thermodilution (by PiCCO) versus an oesophageal doppler monitor (CardioQ) They will be used simultaneously
Other Names:
  • PiCCO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac output
Time Frame: 24 hours
liter/m2/minute
24 hours
stroke volume
Time Frame: 24 hours
milliliters
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
flow time corrected
Time Frame: 24 hours
seconds
24 hours
stroke distance
Time Frame: 24 hours
centimeters
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Study Chair: Gert Jan Scheffer, prof. dr, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2017

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

May 29, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • NL57824.091.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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