Recruiting

Pulse Oximeter Accuracy

Sponsor:

Rush University Medical Center

Code:

NCT07415187

Conditions

Accuracy of Pulse Oximetry Across Skin Pigmentation Levels

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

There is no intervention

Study Details

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.

Conditions

Accuracy of Pulse Oximetry Across Skin Pigmentation Levels

Study ID

NCT07415187

Start date

Apr 1, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

194 participants

Anticipated

Interventions and Outcome Measures

Interventions

There is no intervention

There is no intervention

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 and Locations

Central contacts

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60607

Contacts

More Information

Sponsor

Rush University Medical Center

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-02-17.