SpO2 Infant and Pediatric Study (NCT07615738) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
SpO2 Infant and Pediatric Study
United States180 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
29 Days – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collection of SpO2 Percentage Sensor Data with simultaneous SaO2 values
Timeframe: From enrollment to the end of standard of care arterial cannulation, approximately 1 week.