Hypoxemia, Pulse Oximetry, Skin Pigment
Conditions
Keywords
Hospitalized Patients
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.
Detailed description
This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols: 1. precise time-matching paired blood gas samples to stable periods of pulse oximeter readings 2. objective quantification of skin pigmentation rather than using documented or self-reported race 3. 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.
Interventions
OTHERObservational
No interventions planned. Observational data collection only.
Sponsors
Food and Drug Administration (FDA)
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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% |
Countries
United States
Outcome results
None listed