Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation

Completed

• Conditions: Pulse Oximetry; Hypoxemia; Skin Pigment
• Interventions: Other: Observational

• Registration Number: NCT05554510
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2022-08-14
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Primary Completion: 2024-08-20
• Study Completion: 2024-08-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 757

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized Patients with Arterial Catheters	Observational	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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%

Trial Locations

Locations (1)

Zuckerberg San Francisco General and UCSF Health; 🇺🇸 San Francisco, California, United States