Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation

Hypoxemia Clinical Trial

— EquiOx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554510
• Other study ID #: 22-36553
• Status: Recruiting
• Start date: August 14, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Philip Bickler, MD, PhD
• Phone: 628-206-9966
• Email: philip.bickler[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia
• Pulse Oximetry
• Skin Pigment

Intervention

Other:
• Observational
No interventions planned. Observational data collection only.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General and UCSF Health	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse Oximetry Errors	Pulse oximeter bias (difference between SpO2 and SaO2)	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	Occult Hypoxemia Rates	Episodes of arterial blood gas functional saturation <90% with simultaneous pulse oximeter reading >/=92%	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