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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxemia; Skin Pigment; Pulse Oximetry
• Intervention / Treatment: Other: Observational

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Philip Bickler, MD, PhD; Phone Number: 628-206-9966; Email: philip.bickler@ucsf.edu
• Study Contact Backup: Name: Hypoxia Lab UCSF; Phone Number: 628-206-9966; Email: hypoxialab@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94111
      • Recruiting
      • Zuckerberg San Francisco General and UCSF Health
      • Contact: Philip E Bickler, MD, PhD; Phone Number: 415-476-1411; Email: philip.bickler@ucsf.edu
      • Contact: Caroline E Hughes, BA; Phone Number: (628) 206 7736; Email: caroline.hughes@ucsf.edu
      • Principal Investigator: Carolyn M Hendrickson, MD
      • Sub-Investigator: Michael Lipnick, MD
      • Sub-Investigator: John Feiner, MD
      • Sub-Investigator: Tyler Law, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients at risk for hypoxemia with arterial lines placed for clinical purposes.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hospitalized Patients with Arterial Catheters	Other: Observational; No interventions planned. Observational data collection only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Philip Bickler, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hospitalized Patients
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 22-36553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data without private health information or individual identifiers will be made available via the Open Oximetry Project. De-identified data without sensitive information or identifiers will be shared as outlined in the IRB protocol with the study sponsor, the Unites States Food and Drug Administration.
• IPD Sharing Time Frame: Upon study completion, approximately October 2023 and in accordance with any peer-reviewed journal requirements.
• IPD Sharing Access Criteria: Qualified researchers with appropriate training in Human Subjects Research protocols and without conflicts of interest in data analysis or publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No