PRecision Integrated Saturation Monitor for Congenital Heart Disease
This study, called PRecision Integrated Saturation Monitor (PRISM), is looking at a new way to measure oxygen levels in babies with congenital heart disease (CHD) or single ventricle heart disease. It aims to see if an abdominal pulse oximeter (a device that measures oxygen in the blood) works as well as the usual fingertip devices. Researchers will collect information from your baby's medical chart while they are in the intensive care unit. Your baby will be part of the study for 3 days, and no extra visits or procedures are needed. The study is open to babies aged 0 to 12 months who weigh more than 2 kg and have an arterial line (a small tube in an artery) in place as part of their standard care. The main goal is to compare the oxygen readings from the abdominal device with the standard oxygen measurements.
- Study design
- This is an observational study planning to enroll 100 participants. It will compare a new abdominal pulse oximeter to traditional fingertip readings and gold standard measurements.
- What's involved
- Your baby will be in the study for 3 days while receiving standard hospital care. Researchers will collect routine data from their medical chart; no additional study visits or procedures are required.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from enrollment to the end of the study at 72 hours.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PRecision Integrated Saturation Monitor
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Abdominal SpO2 versus SaO2From enrollment to end of study at 72 hours.
The primary outcome is the accuracy of abdominal SpO₂ versus SaO₂, measured as root mean square error (RMSE); target ≤ 3.0% RMSE.