Pulse Oximeter Accuracy in Healthy Humans During Hypoxia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorUniversity of California, San Francisco
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Study population consists of healthy volunteers between 18-50 years of age across all ethnic and racial backgrounds.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Controlled desaturation (hypoxemia)
DeviceStable hypoxemia is created in healthy subjects by having them breathe hypoxic air mixtures
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
SpO2
Reading on pulse oximeter device which is an estimate of the patient's blood oxygen level.
Time frame
08/01/2025Secondary outcomes
1
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%.
Time frame
08/01/20252
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.
Time frame
08/01/20253
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.
Time frame
08/01/20254
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.
Time frame
08/01/2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov