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The Impact of Skin Tone on Pulse Oximeter Accuracy

The Impact of Skin Tone on Pulse Oximeter Accuracy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07415187
Enrollment
194
Registered
2026-02-17
Start date
2023-04-01
Completion date
2027-12-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accuracy of Pulse Oximetry Across Skin Pigmentation Levels

Brief summary

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.

Interventions

OTHERThere is no intervention

There is no intervention

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients admitted to an intensive care unit, general medicine/surgery wards, or visiting the pulmonary function labs and/or outpatient pulmonary services clinics at Rush University Medical Center * Patient has an existing order for an arterial blood gas analysis \[arterial line or puncture\]

Exclusion criteria

* Patients with heavy scar tissue on the sensor site * Patients with hand tremors * Opaque nail polish that cannot be removed

Design outcomes

Primary

MeasureTime frame
Difference between pulse oximeter oxygen saturation and arterial oxygen saturationAt the time of clinically indicated arterial blood gas sampling (single time point)

Countries

United States

Contacts

CONTACTBrady Scott, PhD
jonathan_b_scott@rush.edu13129426389

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026