Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Clinical Study of Pulse Oximeter Errors in Hospitalized Patients With Varying Skin Pigmentation

Conditions
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Hypoxemia, Pulse Oximetry, Skin Pigment

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Profound anemia, defined as hemoglobin < 8 g/dl will preclude blood draws for research purposes Known pregnancy In custody of law enforcement officials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized Patients with Arterial Catheters<br> | Other: Observational<br>* No interventions planned. Observational data collection only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospitalized Patients