Generalised Melanin PigmentationO2SATSNCT06298422
Oxygen Saturations Across Tones of Skin
An observational study of Generalised Melanin Pigmentation and Pulse Oximetry, run by University of California, San Diego at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Generalised Melanin Pigmentation, Pulse Oximetry
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients on mechanical ventilation.
Who may be able to join
- >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
- 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)
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Generalised Melanin Pigmentation, Pulse Oximetry
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference observed between SpO2 and SaO2.
Arterial Blood Gas
Measured: Through study completion, approximately one year
Melanin Index
Spectrophotometry
Measured: Through study completion, approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalised Melanin PigmentationStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Cotton, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298422
- Sponsor's protocol ID
- 806433
- Acronym
- O2SATS
- Status last verified
- May 2024
- First submitted
- 22 Feb 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Race-Based Limitations in Pulse Oximetry Through Colorimeter or Spectrophotometer-Integrated Corrections
- ClinicalTrials.gov ID
- NCT06298422
- Acronym / sponsor ID
- O2SATS / 806433
- Conditions
- Generalised Melanin Pigmentation, Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients on mechanical ventilation.
Key inclusion criteria (8 listed)
- >18 years old
- Any gender
- Any ethnic background
- Admitted to UC San Diego La Jolla or Hillcrest campus ICU
- Mechanically ventilated
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference observed between SpO2 and SaO2.
Time frame: Through study completion, approximately one year
Arterial Blood Gas
Melanin Index
Time frame: Through study completion, approximately one year
Spectrophotometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalised Melanin Pigmentation and Pulse Oximetry, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference observed between SpO2 and SaO2. (time frame: Through study completion, approximately one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.