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.

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NCT07686341

PRecision Integrated Saturation Monitor

Recruiting
Not specifiedAges 0–12Observational
Le Bonheur Children's Hospital
~100 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:vital sign monitoring

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Abdominal SpO2 versus SaO2
Measured over From enrollment to end of study at 72 hours.
CHD - Congenital Heart Disease
Single Ventricle Heart Disease
1 sites across 1 states
Tennessee1

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Eligibility criteria

Inclusion

0-12 months of age. (Must be less than 1 year of life for the pulse oximeter portion of the study) Weight greater than 2 Kg at time of study
Admitted to an intensive care unit. (Not applicable for outpatient cohort)
Arterial line in place as standard of care (Not applicable for outpatient cohort)
Informed consent provided by parent or LAR.

Exclusion

Open Sternum
Skin abnormalities at the proposed sensor site (e.g., rash, eczema, wounds, stoma, or infection)
Known allergy or sensitivity to adhesives or materials used in the sensor
Excessive movement or irritability that precludes safe and effective placement of the sensor
Parent or legal guardian unable to provide informed consent
  • 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.