Validation of CardioQ Versus PiCCO in Children

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03172689

Acronym

CQPiCCO

Enrollment

Registered

2017-06-01

Start date

2017-08-29

Completion date

2025-07-01

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output

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.

Interventions

DEVICECardioQ

comparison of cardiac output measurements between gold standard transpulmonary thermodilution (by PiCCO) versus an oesophageal doppler monitor (CardioQ) They will be used simultaneously

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

children with an clinical indication for cardiac output monitoring in ICU or OR

Eligibility

Sex/Gender

ALL

Age

3 Months to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
cardiac output	24 hours	liter/m2/minute
stroke volume	24 hours	milliliters

Secondary

Measure	Time frame	Description
flow time corrected	24 hours	seconds
stroke distance	24 hours	centimeters

Countries

Netherlands

Contacts

STUDY_CHAIRGert Jan Scheffer, prof. dr

Radboud University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026