SpO2 Infant and Pediatric Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29-12
SponsorGE Healthcare
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SpO2 Sensor
Treatment groups
180 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov