Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

NCT06142019 | Recruiting FDA Device

• 1 other identifier: 21-35637
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxia; Skin Pigmentation

Outcome Measures

Primary Outcomes (1)

• SpO2

  Reading on pulse oximeter device which is an estimate of the patient's blood oxygen level.

  08/01/2025

Secondary Outcomes (4)

• Blood gas SO2

  08/01/2025

• Skin Pigmentation by ITA

  08/01/2025

• Finger Diameter

  08/01/2025

• Skin Pigmentation by Monk Scale

  08/01/2025

Interventions

Controlled desaturation (hypoxemia) DEVICE

Stable hypoxemia is created in healthy subjects by having them breathe hypoxic air mixtures

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study population consists of healthy volunteers between 18-50 years of age across all ethnic and racial backgrounds.

You may qualify if:

• The subject is male or female, aged ≥18 and \<50.
• The subject is in good general health with no evidence of any medical problems.
• The subject is fluent in both written and spoken English.
• The subject has provided informed consent and is willing to comply with the study procedures.

You may not qualify if:

• The subject is obese (BMI\>35).
• The subject has a known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP.
• Subject has diabetes.
• Subject has a clotting disorder.
• The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
• The subject has any other serious systemic illness.
• The subject is a current smoker.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity to local anesthesia.
• The subject has a diagnosis of Raynaud's disease.
• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• The subject is pregnant, lactating or trying to get pregnant.
• The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Hypoxia Lab, UCSF Department of Anesthesia and Perioperative Care

San Francisco, California, 94143, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 20007731 BACKGROUND

• 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.

  PMID: 18048893 BACKGROUND

• 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.

  PMID: 15791098 BACKGROUND

MeSH Terms

Conditions

Hypoxia; Pigmentation Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Philip E Bickler, MD, PhD

  University of California at San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phil Bickler, MD, PhD

CONTACT

415-476-1411; Philip.bickler@ucsf.edu

Michael Lipnick, MD

CONTACT

628-206-7736; Michael.lipnick@ucsf.edu

Study Design

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

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: November 21, 2023
• Study Start: November 29, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)