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Oxygen Saturations Across Tones of Skin

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06298422
Acronym
O2SATS
Enrollment
20
Registered
2024-03-07
Start date
2024-04-01
Completion date
2025-06-30
Last updated
2024-05-08

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

Conditions

Generalised Melanin Pigmentation, Pulse Oximetry

Brief 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.

Interventions

None listed

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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) \-

Design outcomes

Primary

MeasureTime frameDescription
Difference observed between SpO2 and SaO2.Through study completion, approximately one yearArterial Blood Gas
Melanin IndexThrough study completion, approximately one yearSpectrophotometry

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026