Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation (EquiOx)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Skin Pigment; Pulse Oximetry; Hypoxemia

Treatments: Other: Observational

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05554510

22-36553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 1 patient group

Hospitalized Patients with Arterial Catheters

Treatment:

Other: Observational