The Impact of Skin Tone on Pulse Oximeter Accuracy

Conditions

• Accuracy of Pulse Oximetry Across Skin Pigmentation Levels

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• There is no intervention — OTHER
  There is no intervention

Study Details

Pulse oximeters are widely used in hospitals to estimate blood oxygen levels using a sensor placed on the skin. Recent studies suggest that pulse oximeter readings may be less accurate in individuals with darker skin tones, which could delay recognition of low oxygen levels. The purpose of this study is to evaluate the accuracy of pulse oximeters across a range of skin tones and to identify factors associated with differences between pulse oximeter readings and oxygen levels measured directly from blood. This is an observational cohort study involving adult patients who are already undergoing an arterial blood gas (ABG) test as part of routine clinical care. The ABG test is not performed for research purposes and is not altered by participation in the study. At the time the ABG sample is obtained, two commercially available pulse oximeters will be temporarily placed on the participant's finger to record oxygen saturation values. These readings will be compared with the oxygen saturation measured from the arterial blood sample. Pulse oximeter measurements collected for the study will not be used for clinical decision-making. Skin tone will be assessed using both self-reported race/ethnicity and an objective, noninvasive skin pigmentation measurement device. This approach allows evaluation of the relationship between skin pigmentation and pulse oximeter accuracy. Participation in the study involves minimal risk. No additional blood samples, medications, or treatments are required. The study does not alter standard medical care. The findings from this study may improve understanding of pulse oximeter performance and help inform future efforts to reduce measurement bias and improve patient safety.

Key Dates

Start date

Apr 1, 2023

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

194 participants (estimated)

Primary Outcome Measure

Difference between pulse oximeter oxygen saturation and arterial oxygen saturation [ Time Frame: At the time of clinically indicated arterial blood gas sampling (single time point) ]

Central Contacts

• Brady Scott, PhD
  13129426389
  [email protected]

Locations (1)

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