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RECRUITING
NCT07686341

PRecision Integrated Saturation Monitor

Sponsor: Le Bonheur Children's Hospital

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

0 Months - 12 Months

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-08

Completion Date

2028-12

Last Updated

2026-07-07

Healthy Volunteers

No

Interventions

DEVICE

vital 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