Impact of skin pigmentation on pulse oximeter accuracy
Impact of Skin Pigmentation on Accuracy of Pulse Oximetry
This study is testing how well different pulse oximeters measure oxygen levels in patients with various skin colors to see if skin pigmentation affects their accuracy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 232 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05690269 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the accuracy of various FDA-approved pulse oximeters in measuring arterial oxygen saturation (SaO2) across patients with different skin pigmentation. The study involves patients in the Intensive Care Unit who have arterial lines, and it compares SpO2 readings from multiple oximeters against reference values obtained from arterial blood gas measurements. The oximeters will be randomized across different fingers and hands to minimize bias, and measurements will be taken when SpO2 is below 97%. The goal is to understand how skin pigmentation affects the reliability of pulse oximetry.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the Intensive Care Unit and have an arterial line.
Not a fit: Patients who do not require arterial blood gases or have conditions like methemoglobinemia or those in isolation due to multi-resistant bacteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy in pulse oximetry readings for patients with varying skin pigmentation, enhancing patient care.
How similar studies have performed: While the impact of skin pigmentation on pulse oximetry has been discussed, this specific approach of comparing multiple oximeters in a controlled ICU setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years old * Patients admitted to the Intensive Care Unit * Patient has arterial line Exclusion Criteria: * No signal with the oximeter * Missing digits preventing application of all probes simultaneously * No requirement for arterial blood gases * Pigmented nails, fake nails, or nail polish * Methemoglobinemia * Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19)
Where this trial is running
Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Dina Gomaa, MSc — University of Cincinnati
- Study coordinator: Dina Gomaa, MSc
- Email: gomaada@ucmail.uc.edu
- Phone: 5135586305
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.