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PRecision Integrated Saturation Monitor

PRISM: PRecision Integrated Saturation Monitor A Novel Approach to Monitoring Oxygen Saturation in Children A Prospective, Observational, Comparative Validation Clinical Study to Evaluate the Accuracy of a Novel Abdominal Pulse Oximeter With Integrated Motion Detection and Skin Tone Calibration Against Arterial Blood Gas (SaO₂) Measurements and Conventional Fingertip Pulse Oximetry (SpO₂) in Pediatric Patients.

Who can join

0 Months – 12 Months · All sexes

Inclusion Criteria:

* 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 Criteria:

* 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

About the study

The purpose of this study is to find out if an abdominal pulse oximeter device is as accurate as a conventional fingertip pulse oximeter in pediatric patients. In this study, we will be collecting data from your medical record while you are being treated in the hospital for your clinical care. Your baby will be in the study for 3 days. There will be no additional study visits. We will collect information already being obtained while your baby is at the hospital.

What is being tested

• vital sign monitoring (device)

Sponsor: Le Bonheur Children's Hospital · Participants: 100 · Started: 2026-08

Contact the study team

Official record on ClinicalTrials.gov — NCT07686341

Locations in the U.S.

Conditions

• Congenital Heart Defects
• Univentricular Heart

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.