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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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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.
This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized Patients with Arterial Catheters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | No interventions planned. Observational data collection only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Oximetry Errors | Pulse oximeter bias (difference between SpO2 and SaO2) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occult Hypoxemia Rates | Episodes of arterial blood gas functional saturation <90% with simultaneous pulse oximeter reading >/=92% | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients at risk for hypoxemia with arterial lines placed for clinical purposes.
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| Name | Affiliation | Role |
|---|---|---|
| Philip Bickler, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General and UCSF Health | San Francisco | California | 94111 | United States |
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.
Upon study completion, approximately October 2023 and in accordance with any peer-reviewed journal requirements.
Qualified researchers with appropriate training in Human Subjects Research protocols and without conflicts of interest in data analysis or publication.
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |