Clinical trial NCT05554510: Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation
Official title: Prospective Clinical Study of Pulse Oximeter Errors in Hospitalized Patients With Varying Skin Pigmentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxemia
Pulse Oximetry
Skin Pigment
Keywords: Hospitalized Patients
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2022-09-26
Enrollment: 757
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients at risk for hypoxemia with arterial lines placed for clinical purposes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulse Oximetry Errors
timeFrame: 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:
measure: Occult Hypoxemia Rates
timeFrame: 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
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General and UCSF Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Philip Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: