EquiOx: Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation
Study Details
Study Description
Brief 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 blood SaO2 <90% when their pulse oximeter reads 92% or greater.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols:
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precise time-matching paired blood gas samples to stable periods of pulse oximeter readings
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objective quantification of skin pigmentation rather than using documented or self-reported race
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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
Arms and Interventions
Arm | Intervention/Treatment |
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Hospitalized Patients with Arterial Catheters
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Other: Observational
No interventions planned. Observational data collection only.
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Outcome Measures
Primary Outcome Measures
- Pulse Oximetry Errors [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)
Secondary Outcome Measures
- Occult Hypoxemia Rates [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]
Episodes of arterial blood gas functional saturation <90% with simultaneous pulse oximeter reading >/=92%
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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hospitalized and at high risk of hypoxemia, defined as saturations < 90%,
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patients with arterial line in place for clinical purposes
Exclusion Criteria:
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Profound anemia, defined as hemoglobin < 8 g/dl will preclude blood draws for research purposes
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Known pregnancy
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In custody of law enforcement officials
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Zuckerberg San Francisco General and UCSF Health | San Francisco | California | United States | 94111 |
Sponsors and Collaborators
- University of California, San Francisco
- Food and Drug Administration (FDA)
Investigators
- Principal Investigator: Philip Bickler, MD, PhD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-36553