Pulse Oximetry Errors in Hospitalized Patients Across Varying Skin Pigmentation

NCT05554510 | Completed DMC

• 1 other identifier: 22-36553
• Study Type: observational
• Target: 757
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia; Pulse Oximetry; Skin Pigment

Keywords

Hospitalized Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (1)

Hospitalized Patients with Arterial Catheters

Other: Observational

Interventions

Observational OTHER

No interventions planned. Observational data collection only.

Hospitalized Patients with Arterial Catheters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Profound anemia, defined as hemoglobin \< 8 g/dl will preclude blood draws for research purposes
• Known pregnancy
• In custody of law enforcement officials

Sponsors & Collaborators

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

Study Sites (1)

Zuckerberg San Francisco General and UCSF Health

San Francisco, California, 94111, United States

Location

MeSH Terms

Conditions

Hypoxia; Pigmentation Disorders

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Philip Bickler, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 26, 2022
• Study Start: August 14, 2022
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon study completion, approximately October 2023 and in accordance with any peer-reviewed journal requirements.
• Access Criteria: Qualified researchers with appropriate training in Human Subjects Research protocols and without conflicts of interest in data analysis or publication.

Locations

US (1)