Could a less invasive heart monitor replace the standard in sick children?
NCT ID NCT03172689
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study compares a less invasive device that uses sound waves to measure blood flow from the heart (esophageal Doppler) with a standard, more invasive method (transpulmonary thermodilution) in children who are sedated and on breathing machines. The goal is to see if the gentler approach gives equally reliable readings of cardiac output and stroke volume. If it does, it could offer a safer way to monitor heart function in critically ill young patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CardioQ (esophageal Doppler cardiac output monitor) compared to PiCCO (transpulmonary thermodilution cardiac output monitor)
- What this could lead to
- If successful, this could validate a less invasive way to measure heart function in critically ill children, potentially reducing risks associated with more invasive monitoring.
- What could go wrong
- This is a small validation study with only 11 participants, so results may not apply broadly. The device may not match the accuracy of the standard method.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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11 people
The number who actually took part.
- Started
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Aug 2017
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 months to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Radboud Univeristy Medical Center
Nijmegen, Gelderland, 6500 HB, Netherlands
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