Evaluating pulse oximetry accuracy in children with darker skin pigmentation
Official title: Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children With Darker Skin Pigmentation
Run by Stanford University · NCT05617547 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to see if pulse oximeters give accurate readings of blood oxygen levels in children with darker skin to help ensure everyone gets the right care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 21 Years |
| Sex | All |
| Enrollment | 154 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05617547 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 21 years or younger who require arterial vascular access as part of their routine clinical care.
✕Probably not a fit
Patients with conditions like anemia, methemoglobinemia, or those who are non-pulsatile may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to enroll 154 children with arterial lines to assess the accuracy of pulse oximeters in those with darker skin pigmentation. It seeks to determine if pulse oximeters overestimate blood oxygen levels, a concern highlighted in adult studies but less explored in pediatric populations. By measuring skin pigmentation objectively and correlating it with pulse oximetry readings, the study aims to identify potential biases that could lead to health disparities. The research is funded by the FDA through the Stanford-UCSF Clinical Excellence in Regulatory Science and Innovation Program.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of pulse oximetry in children with darker skin, leading to better clinical outcomes and reduced health disparities.
How similar studies have gone: While prior studies have indicated potential biases in pulse oximetry, this prospective approach focusing on pediatric patients with darker skin pigmentation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≤21 years of age 2. Requires arterial vascular access as part of routine clinical care 3. Patient or legally authorized representative (LAR) willing to provide written informed consent Exclusion Criteria: 1. Anemia defined as a Hgb \<8 g/dL 2. Methemoglobinemia or carbon monoxide poisoning where the SpO2 is known to be inaccurate 3. Skin condition, such as epidermolysis bullosa, where pulse oximetry not expected to be accurate, or application of skin probes is medically inadvisable 4. Non-pulsatile patients (e.g., left ventricular assist device (LVAD), extracorporeal membrane oxygenation (ECMO) 5. Lack of informed consent
Where it's running
-
Lucile Packard Children's Hospital
Palo Alto, California, United States Recruiting
Study contacts
- Study coordinator: Christopher S Almond, MD, MPH
- Email: calmond@stanford.edu
- Phone: 650-7237913
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.