SpO2, SpO2 (Peripheral Oxygen Saturation) Measurement Validation
Conditions
Brief 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.
Detailed description
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. The safety objective is to collect safety information, including type and number of AEs, SAEs, and device issues. Results may support product development, regulatory submissions, and marketing activities.
Interventions
DEVICESpO2 Sensor
SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Days to 12 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of SpO2 Percentage Sensor Data with simultaneous SaO2 values | From enrollment to the end of standard of care arterial cannulation, approximately 1 week. | The collection of SpO2 percentage sensor data with simultaneous SaO2 values percentage from each subject enrolled in the study. |
Countries
United States
Outcome results
None listed