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NCT07615738
SpO2 Infant and Pediatric Study
Conditions: SpO2 (Peripheral Oxygen Saturation) Measurement Validation, SpO2
Sex: All
Ages: 29 Days – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 180
Sponsor: GE Healthcare
Location: University of Nebraska Medical Center Children's Hospital Omaha Nebraska
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Fractional Methemoglobinemia (FMetHb \>2%) or Fractional carboxyhemoglobinemia (FCOHb \>3%), within 24 hours of arterial blood draw.
* Severe anemia (tHb \
Source: ClinicalTrials.gov (NCT07615738). StuddyBuddy aggregates publicly available trial information.
