Assessment of TruSignal SpO2 Form, Fit and Clinical Performance With Infant and Child Patients
GE Healthcare
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.
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of simultaneously drawn arterial blood, using methods aligned with ISO 80601-2-61 (3rd edition CD draft) and FDA draft guidance. Secondary objectives include measuring the proportion of time the device produces invalid or unusable data to assess reliability for clinical…
Eligibility
- Age range
- 0–12 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * subjects are 1-23 months (infant cohort) or 2-12 years old (pediatric 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…
Interventions
- DeviceSpO2 Sensor
SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.
Location
- University of Nebraska Medical Center Children's HospitalOmaha, Nebraska