Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298422
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-08
First Post:
2024-02-22
Brief Title:
Oxygen Saturations Across Tones of Skin
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Addressing Race-Based Limitations in Pulse Oximetry Through Colorimeter or Spectrophotometer-Integrated Corrections
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
O2SATS
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None