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Completed

NCT Number: NCT03172689

Validation of CardioQ Versus PiCCO in Children

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.

Completed

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Key information

Conditions

Cardiac Output

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud Univeristy Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CardioQ

Device

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

Primary outcomes

  1. cardiac output

    Time frame: 24 hours

    liter/m2/minute

  2. stroke volume

    Time frame: 24 hours

    milliliters

Secondary outcomes

  1. flow time corrected

    Time frame: 24 hours

    seconds

  2. stroke distance

    Time frame: 24 hours

    centimeters

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: CQPiCCO

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2017
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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