SpO2 Infant and Pediatric Study
Starting soon · Not applicable
Conditions studied: SpO2 (Peripheral Oxygen Saturation) Measurement Validation, SpO2
In brief
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.
Key facts
- Study ID
- NCT07615738
- Run by
- GE Healthcare
- People needed
- 180
- Starts
- 2026-06-15
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-01
Who can join
Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- subjects are 1-23 months (infant cohort) or 2-12 years old (child cohort)
- requiring arterial blood samples per the site's standard of care.
You may not qualify if…
- Fractional Methemoglobinemia (FMetHb >2%) or Fractional carboxyhemoglobinemia (FCOHb >3%), within 24 hours of arterial blood draw.
- Severe anemia (tHb <7g/dL) within 4 hours prior to arterial blood gas draw.
- Hematocrit (Hct) <25 within 4 hours prior to arterial blood gas draw.
- Patients with injuries, deformities, or abnormalities which may prevent proper application of the sensor.
- Patients on Extracorporeal Membrane Oxygenation (ECMO).
- Patients receiving point of care (POC) testing for blood gases.
- Patients with diseases/conditions that may cause differential (or reverse differential) cyanosis including, but not limited to:
- Patent ductus arteriosus with pulmonary arterial hypertension.
- Pulmonary hypertension and left-heart abnormalities aortic arch hypoplasia, interrupted aortic arch, critical coarctation, and critical aortic stenosis.
- Children with transposition of the great arteries (TGA) and coarctation of the aorta or interrupted aortic arch, and TGA with suprasystemic pulmonary vascular resistance.
- At the discretion of the principal investigator or designee due to the subject health condition.
Where it is running
- University of Nebraska Medical Center Children's Hospital — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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