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NOT YET RECRUITING
NCT07615738
NA

SpO2 Infant and Pediatric Study

Sponsor: GE Healthcare

View on ClinicalTrials.gov

Summary

This study evaluates the pulse oximetry (SpO₂) sensor for clinical performance, form, and fit in hospitalized infants and children (28 days to 12 years). It compares SpO₂ measurements from the device to arterial oxygen saturation (SaO₂) values from arterial CO-oximetry, and assesses the reliability of usable data, performance across skin tones, and user feedback.

Official title: Assessment of TruSignal SpO2 Form, Fit and Clinical Performance With Infant and Child Patients

Key Details

Gender

All

Age Range

29 Days - 12 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-06-15

Completion Date

2027-12-31

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

DEVICE

SpO2 Sensor

SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.

Locations (1)

University of Nebraska Medical Center Children's Hospital

Omaha, Nebraska, United States