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NCT03172689 Clinical Trial

Validation of CardioQ Versus PiCCO in Children

Cardiac Output Clinical Trial

— CQPiCCO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03172689
Other study ID # NL57824.091.16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 29, 2017
Est. completion date February 1, 2024

Study information
Verified date November 2022
Source Radboud University Medical Center
Contact Marieke Voet, drs
Phone 0031 24 3614406
Email Marieke.Voet@radboudumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 17
Est. completion date February 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands Radboud Univeristy Medical Center Nijmegen Gelderland

Sponsors (1)
Lead Sponsor Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary cardiac output liter/m2/minute 24 hours
Primary stroke volume milliliters 24 hours
Secondary flow time corrected seconds 24 hours
Secondary stroke distance centimeters 24 hours
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