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OpenTrials
Completed

NCT Number: NCT05554510

Pulse Oximetry Errors in Hospitalized Patients Across 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuckerberg San Francisco General and UCSF Health

San Francisco, California, 94111, United States

About this study

This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols:

  • precise time-matching paired blood gas samples to stable periods of pulse oximeter readings
  • objective quantification of skin pigmentation rather than using documented or self-reported race
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

No interventions planned. Observational data collection only.

Primary outcomes

  1. Pulse Oximetry Errors

    Time frame: 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 outcomes

  1. Occult Hypoxemia Rates

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Food and Drug Administration (FDA)

Registry information

Official study title

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

Acronym: EquiOx

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2022
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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