Zuckerberg San Francisco General and UCSF Health
San Francisco, California, 94111, United States
NCT Number: NCT05554510
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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Notify Me18 year and older
All sexes
Observational
San Francisco, California, 94111, United States
This prospective study will overcome the limitations of earlier retrospective studies using three important study protocols:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No interventions planned. Observational data collection only.
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)
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%
University of California, San Francisco
Other
Prospective Clinical Study of Pulse Oximeter Errors in Hospitalized Patients With Varying Skin Pigmentation
Acronym: EquiOx
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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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