SpO2 Infant and Pediatric Study

ConditionsSpO2 (Peripheral Oxygen Saturation) Measurement Validation SpO2

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

SpO2 Sensor
Device
SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.

Treatment groups

180 Participants

are divided into 1 treatment group

Group A: All SubjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Collection of SpO2 Percentage Sensor Data with simultaneous SaO2 values

The collection of SpO2 percentage sensor data with simultaneous SaO2 values percentage from each subject enrolled in the study.

Time frame

From enrollment to the end of standard of care arterial cannulation, approximately 1 week.

Other outcomes

Incidence of Safety Events

Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.

Time frame

4 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GE Healthcare

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: