HypoxemiaEquiOxNCT05554510
Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation
An observational study of Hypoxemia and Pulse Oximetry, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a prospective observational study designed to quantify and understand errors in pulse oximetry in hospitalized patients in relation to their skin pigmentation. It is driven by three recent retrospective studies showing missed diagnosis of hypoxemia in patients across a spectrum of skin pigmentation, defined as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Pulse Oximetry, Skin Pigment
- What is being tested?
- Observational
- How many people
- 757 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2022to 20 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients at risk for hypoxemia with arterial lines placed for clinical purposes.
Who may be able to join
- 18 years of age or older
- hospitalized and at high risk of hypoxemia, defined as saturations < 90%,
- patients with arterial line in place for clinical purposes
Who cannot join
- Profound anemia, defined as hemoglobin < 8 g/dl will preclude blood draws for research purposes
- Known pregnancy
- In custody of law enforcement officials
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General and UCSF Health
San Francisco, California, 94111
About this study
Official title: Prospective Clinical Study of Pulse Oximeter Errors in Hospitalized Patients With Varying Skin Pigmentation
This is a prospective observational study designed to quantify and understand errors in pulse oximetry in hospitalized patients in relation to their skin pigmentation. It is driven by three recent retrospective studies showing missed diagnosis of hypoxemia in patients across a spectrum of skin pigmentation, defined as blood SaO2 <90% when their pulse oximeter reads 92% or greater.
Read the detailed description
This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols:
- precise time-matching paired blood gas samples to stable periods of pulse oximeter readings
- objective quantification of skin pigmentation rather than using documented or self-reported race
- collection of high quality pulse oximeter tracing data, and identifying potential mediators of discordance of noninvasive and invasive measurements such as low perfusion states.
The primary aim is to quantify the bias in SpO2 measurements across skin pigmentation groups in a real-world setting against the gold standard of invasive measurements of arterial blood oxygen saturation measurements across categories of skin pigmentation. These data are essential to addressing health equity and patient safety for people of all skin pigmentations.
- Conditions
- Hypoxemia, Pulse Oximetry, Skin Pigment
- Being tested
- Observational
- Keywords
- Hospitalized Patients
- Medical subject headings
- Hypoxia, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
No interventions planned. Observational data collection only.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Patients with Arterial Catheters | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Oximetry Errors
Pulse oximeter bias (difference between SpO2 and SaO2)
Measured: Up to 10 simultaneous, paired arterial blood samples and noninvasive pulse oximeter readings obtained during unpredictable qualifying episodes of low oxygen saturation identified by clinically indicated monitoring over a 14-day study period
Secondary outcomes (1)
Occult Hypoxemia Rates
Episodes of arterial blood gas functional saturation <90% with simultaneous pulse oximeter reading >/=92%
Measured: Up to 10 simultaneous, paired arterial blood samples and noninvasive pulse oximeter readings obtained during unpredictable qualifying episodes of low oxygen saturation identified by clinically indicated monitoring over a 14-day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start14 Aug 2022
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Philip Bickler, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554510
- Sponsor's protocol ID
- 22-36553
- Acronym
- EquiOx
- Status last verified
- Feb 2025
- First submitted
- 9 Sep 2022
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data without private health information or individual identifiers will be made available via the Open Oximetry Project. De-identified data without sensitive information or identifiers will be shared as outlined in the IRB protocol with the study sponsor, the Unites States Food and Drug Administration.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Pulse Oximeter Errors in Hospitalized Patients With Varying Skin Pigmentation
- ClinicalTrials.gov ID
- NCT05554510
- Acronym / sponsor ID
- EquiOx / 22-36553
- Conditions
- Hypoxemia, Pulse Oximetry, Skin Pigment
- Keywords
- Hospitalized Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 14 Aug 2022 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 26 Sep 2022 (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.
This is a prospective observational study designed to quantify and understand errors in pulse oximetry in hospitalized patients in relation to their skin pigmentation. It is driven by three recent retrospective studies showing missed diagnosis of hypoxemia in patients across a spectrum of skin pigmentation, defined as blood SaO2 <90% when their pulse oximeter reads 92% or greater.
Detailed description
This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols:
- precise time-matching paired blood gas samples to stable periods of pulse oximeter readings
- objective quantification of skin pigmentation rather than using documented or self-reported race
- collection of high quality pulse oximeter tracing data, and identifying potential mediators of discordance of noninvasive and invasive measurements such as low perfusion states.
The primary aim is to quantify the bias in SpO2 measurements across skin pigmentation groups in a real-world setting against the gold standard of invasive measurements of arterial blood oxygen saturation measurements across categories of skin pigmentation. These data are essential to addressing health equity and patient safety for people of all skin pigmentations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Patients with Arterial Catheters | – | Other: Observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients at risk for hypoxemia with arterial lines placed for clinical purposes.
Key inclusion criteria (3 listed)
- 18 years of age or older
- hospitalized and at high risk of hypoxemia, defined as saturations < 90%,
- patients with arterial line in place for clinical purposes
Key exclusion criteria (3 listed)
- Profound anemia, defined as hemoglobin < 8 g/dl will preclude blood draws for research purposes
- Known pregnancy
- In custody of law enforcement officials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNo interventions planned. Observational data collection only. | Other | Hospitalized Patients with Arterial Catheters |
Primary outcome
Pulse Oximetry Errors
Time frame: Up to 10 simultaneous, paired arterial blood samples and noninvasive pulse oximeter readings obtained during unpredictable qualifying episodes of low oxygen saturation identified by clinically indicated monitoring over a 14-day study period
Pulse oximeter bias (difference between SpO2 and SaO2)
1 secondary outcome
Occult Hypoxemia Rates
Time frame: Up to 10 simultaneous, paired arterial blood samples and noninvasive pulse oximeter readings obtained during unpredictable qualifying episodes of low oxygen saturation identified by clinically indicated monitoring over a 14-day study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: Yes. De-identified data without private health information or individual identifiers will be made available via the Open Oximetry Project. De-identified data without sensitive information or identifiers will be shared as outlined in the IRB protocol with the study sponsor, the Unites States Food and Drug Administration.
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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.
Philip Bickler, MD, PhD principal investigator
University of California, San Francisco
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 Hypoxemia and Pulse Oximetry, run by University of California, San Francisco 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulse Oximetry Errors (time frame: Up to 10 simultaneous, paired arterial blood samples and noninvasive pulse oximeter readings obtained during unpredictable qualifying episodes of low oxygen saturation identified by clinically indicated monitoring over a 14-day study period). 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 17 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.