GE Healthcare
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.
This prospective clinical study evaluates a pulse oximetry sensor in hospitalized infants (28 days to 23 months) and children (2-12 years) under routine clinical conditions. The primary objective is to assess the accuracy and agreement of SpO₂ measurements compared with reference SaO₂ values obtained from CO-oximetry analysis of simultaneously drawn arterial blood, using methods aligned with ISO 80601-2-61: 2026 3rd edition published in April 2026. Secondary objectives include measuring the proportion of time the device produces invalid or unusable data to assess reliability for clinical use.…
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 \<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 Extr…
SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.
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