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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06142019
Other study ID # 21-35637
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date August 1, 2025

Study information

Verified date February 2024
Source University of California, San Francisco
Contact Phil Bickler, MD, PhD
Phone 415-476-1411
Email Philip.bickler@ucsf.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxygen. This study will be done on healthy male or females between the age group of 18-50.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Controlled desaturation (hypoxemia)
Stable hypoxemia is created in healthy subjects by having them breathe hypoxic air mixtures

Locations

Country Name City State
United States Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004. — View Citation

Feiner JR, Bickler PE, Mannheimer PD. Accuracy of methemoglobin detection by pulse CO-oximetry during hypoxia. Anesth Analg. 2010 Jul;111(1):143-8. doi: 10.1213/ANE.0b013e3181c91bb6. Epub 2009 Dec 10. — View Citation

Feiner JR, Severinghaus JW, Bickler PE. Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender. Anesth Analg. 2007 Dec;105(6 Suppl):S18-S23. doi: 10.1213/01.ane.0000285988.35174.d9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary SpO2 Reading on pulse oximeter device which is an estimate of the patient's blood oxygen level. 08/01/2025
Secondary Blood gas SO2 Arterial blood gas sample results showing exact SpO2 levels. SpO2 ranges from 1% to 100%. Our target SpO2 levels are between 67% and 100%. 08/01/2025
Secondary Skin Pigmentation by ITA ITA stands for individual typology angle from a spectrophotometer which is an objective measurement of skin pigmentation. The categories for the ITA scale are the following: > 55 Very Light, 41 to 55 Light, 28 to 41 Intermediate, 10 to 28 Tan, -30 to 10 Brown, < -30 Dark. 08/01/2025
Secondary Finger Diameter Finger diameter is measured to ensure that the pulse oximeters being tested work with a variety of finger sizes. Finger diameter is measured in mm. 08/01/2025
Secondary Skin Pigmentation by Monk Scale The Monk scale is a subjective categorization of skin pigmentation. The Monk Scale is a 10 shade scale designed to to be easy-to-use for development and evaluation of technology while presenting a more representative range of skin tones than other common qualitative scales. The Monk Scale is from A to J. A being the lightest skin color and J the darkest. 08/01/2025
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