Oxygen Saturations Across Tones of Skin

Pulse Oximetry Clinical Trial

— O2SATS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06298422
• Other study ID #: 806433
• Status: Enrolling by invitation
• Start date: April 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

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Related Conditions & MeSH terms

• Pulse Oximetry

Locations

Country	Name	City	State
United States	UCSD Health	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference observed between SpO2 and SaO2.	Arterial Blood Gas	Through study completion, approximately one year
Primary	Melanin Index	Spectrophotometry	Through study completion, approximately one year