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SpO2 Infant and Pediatric Study
Sponsor: GE Healthcare
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
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