RecruitingNCT07686341

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.


Sponsor

Le Bonheur Children's Hospital

Enrollment

100 participants

Start Date

Aug 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 MonthsMax Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called vital sign monitoring for people with chd - congenital heart disease and single ventricle heart disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 0 Months to 12 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEvital sign monitoring

The intervention will be to evaluate abdominal SpO2 against both traditional fingertip readings and gold standard SaO2 measurements by collecting routine data from the medical chart that was performed as standard of care.


Locations(1)

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

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NCT07686341


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