Validation of CardioQ Versus PiCCO in Children

Not Applicable

Recruiting

• Conditions: Cardiac Output
• Interventions: Device: CardioQ

• Registration Number: NCT03172689
• Lead Sponsor: Radboud University Medical Center

Brief 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.

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 Timeline

• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Study Start: 2017-08-29
• Status Verified: 2022-11
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-12-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CardioQ	CardioQ	CardioQ will be used as CO monitor simultaneously with the standard of care PiCCO CO monitor

Primary Outcome Measures

Name	Time	Method
cardiac output	24 hours	liter/m2/minute
stroke volume	24 hours	milliliters

Secondary Outcome Measures

Name	Time	Method
stroke distance	24 hours	centimeters
flow time corrected	24 hours	seconds

Trial Locations

Locations (1)

Radboud Univeristy Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands