Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05554510
Study type Observational
Source University of California, San Francisco
Contact Philip Bickler, MD, PhD
Phone 628-206-9966
Email philip.bickler@ucsf.edu
Status Recruiting
Phase
Start date August 14, 2022
Completion date October 1, 2024

See also
  Status Clinical Trial Phase
Suspended NCT03628560 - Alternate Methodology of Pulse Oximeter Validation N/A
Completed NCT02866578 - Open Lung Protective Ventilation in Cardiac Surgery N/A
Recruiting NCT06139081 - Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients With Painless Gastroscopy N/A
Not yet recruiting NCT05964309 - Pre-oxygenation in Sitting Position and Oxygen Reserve Index N/A
Completed NCT00675415 - Does Capnography Prevent Hypoxemia During Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound? N/A
Completed NCT00740220 - Reproducibility of 6 Minute Walk Tests for Oxygen Desaturation N/A
Completed NCT04557605 - Effects of a Face Mask on Oxygenation During Exercise N/A
Active, not recruiting NCT05479929 - Work of Breathing Assessment in Triage Scale
Recruiting NCT05422430 - Rebreathing-induced Hypoxia and Glucose Levels N/A
Recruiting NCT03009643 - Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery N/A
Completed NCT01949012 - Capnography Monitoring During Intravenous Conscious Sedation Sedation With Midazolam for Oral Surgery N/A
Completed NCT01477450 - Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects N/A
Completed NCT01470170 - Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy Phase 4
Recruiting NCT06085859 - Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment N/A
Recruiting NCT03969615 - SuperNO2VA™ and General Anesthesia Postoperative Care N/A
Completed NCT02554110 - Peripheral Nerve Stimulation to Reduce Hypoxic Events N/A
Completed NCT04566419 - poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence N/A
Completed NCT04998253 - Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2 Early Phase 1
Recruiting NCT04079465 - Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia N/A
Recruiting NCT06022523 - Accuracy of Pulse Oximeters With Profound Hypoxia N/A