NCT05554510

Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 757 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxemia
• Pulse Oximetry
• Skin Pigment

Interventions

Type	Name	Description
OTHER	Observational	No interventions planned. Observational data collection only.

Timeline

• Start date: 2022-08-14
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2022-09-26
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States