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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05554510
Study type Observational
Source University of California, San Francisco
Contact Philip Bickler, MD, PhD
Phone 628-206-9966
Email philip.bickler@ucsf.edu
Status Recruiting
Phase
Start date August 14, 2022
Completion date October 1, 2024

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