EquiOx: Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05554510
Collaborator
Food and Drug Administration (FDA) (U.S. Fed)
272
1
14.6
18.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
272 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Clinical Study of Pulse Oximeter Errors in Hospitalized Patients With Varying Skin Pigmentation
Actual Study Start Date :
Aug 14, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Hospitalized Patients with Arterial Catheters

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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%

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zuckerberg San Francisco General and UCSF Health San Francisco California United States 94111

Sponsors and Collaborators

  • University of California, San Francisco
  • Food and Drug Administration (FDA)

Investigators

  • Principal Investigator: Philip Bickler, MD, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT05554510
Other Study ID Numbers:
  • 22-36553
First Posted:
Sep 26, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by University of California, San Francisco
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2022