The Impact of Skin Tone on Pulse Oximeter Accuracy | NCT07415187

Studies
The Impact of Skin Tone on Pulse Oximeter Accuracy

NCT07415187

Sponsor

Rush University Medical Center

Status

Recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

194Estimated

Phase

Not provided

Conditions

Accuracy of Pulse Oximetry Across Skin Pigmentation Levels

Interventions

There is no intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Feb 3, 2026

First Submission Date that Met QC Criteria

Feb 9, 2026

First Posted Date

Feb 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brady Scott, Professor, Program Director, Rush University Medical CenterPrincipal Investigator

Lead Sponsor

Rush University Medical CenterOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

194Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention	Other	There is no intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brady Scott, PhD	Contact	13129426389		jonathan_b_scott@rush.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center	Recruiting	Chicago	Illinois	60607	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33326721	Background	Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available.