Oxygen Saturations Across Tones of Skin (O2SATS)

May 7, 2024 updated by: Shannon Cotton, University of California, San Diego

Addressing Race-Based Limitations in Pulse Oximetry Through Colorimeter or Spectrophotometer-Integrated Corrections

Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Critically ill patients on mechanical ventilation.

Description

Inclusion criteria:

  1. >18 years old
  2. Any gender
  3. Any ethnic background
  4. Admitted to UC San Diego La Jolla or Hillcrest campus ICU
  5. Mechanically ventilated
  6. Has a clinical ABG ordered by the critical care team responsible for clinical care

Exclusion Criteria a. <18 years old b. Medical history of or acute diagnosis of sickle cell disease c. Normally protected individuals under 45 CFR 46 (pregnant individuals, prisoners, and children)

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference observed between SpO2 and SaO2.
Time Frame: Through study completion, approximately one year
Arterial Blood Gas
Through study completion, approximately one year
Melanin Index
Time Frame: Through study completion, approximately one year
Spectrophotometry
Through study completion, approximately one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 806433

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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