NCT06298422

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

February 22, 2024

Last Update Submit

May 7, 2024

Conditions

Generalised Melanin PigmentationPulse Oximetry

Outcome Measures

Primary Outcomes (2)

  • Difference observed between SpO2 and SaO2.

    Arterial Blood Gas

    Through study completion, approximately one year

  • Melanin Index

    Spectrophotometry

    Through study completion, approximately one year

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients on mechanical ventilation.

You may qualify if:

  • \>18 years old
  • Any gender
  • Any ethnic background
  • Admitted to UC San Diego La Jolla or Hillcrest campus ICU
  • Mechanically ventilated
  • Has a clinical ABG ordered by the critical care team responsible for clinical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Health

San Diego, California, 92103, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 7, 2024

Study Start

April 1, 2024

Primary Completion

March 1, 2025

Study Completion

June 30, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

US(1)