RecruitingNCT06142019

Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

Sponsor

University of California, San Francisco

Enrollment

10,000 participants

Start Date

Nov 29, 2021

Study Type

OBSERVATIONAL

Conditions

Hypoxia Skin Pigmentation

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

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.

Exclusion Criteria16

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.
The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.