Evaluating pulse oximetry accuracy in children with darker skin pigmentation
Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children With Darker Skin Pigmentation
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 |
|---|---|
| Enrollment | 154 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05617547 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 21 years or younger who require arterial vascular access as part of their routine clinical care.
Not a fit: Patients with conditions like anemia, methemoglobinemia, or those who are non-pulsatile may not benefit from this study.
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 performed: While prior studies have indicated potential biases in pulse oximetry, this prospective approach focusing on pediatric patients with darker skin pigmentation is relatively novel.
Eligibility criteria
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 this trial is running
Palo Alto, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.