Actively Recruiting
Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia
Led by Movano Health · Updated on 2024-06-14
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Movano Health
Lead Sponsor
U
University of California, San Francisco
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100% per the International Organization for Standardization (ISO) 80601-2-61:2019. Four test devices were placed on each subject on the left or right hand with two at the finger base and two at the fingertip. Motion equipment was used to control motion of the test devices. In addition, two test devices were placed on the contralateral hand on the base of a finger and also on the fingertip. Finally, a test wrist device was placed on either the left or right wrist. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.
CONDITIONS
Official Title
Accuracy of the EvieMED Ring Pulse Oximeter in Profound Hypoxia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is in good general health with no evidence of any medical problems
- Subject is fluent in both written and spoken English
- Subject provided written informed consent and is willing to comply with the study procedures
- Subject is willing to have their skin color assessed
You will not qualify if you...
- Subject is obese with a body mass index (BMI) over 30
- Subject has a known history of heart disease, lung disease, kidney or liver disease
- Subject has asthma, sleep apnea, or uses continuous positive airway pressure breathing support
- Subject has diabetes
- Subject has a clotting disorder or anemia
- Subject has any other serious systemic illness
- Subject is a current smoker
- Subject has any injury, deformity, or abnormality at the sensor sites that could interfere with the sensors
- Subject has a history of fainting or vasovagal response
- Subject has sensitivity to local anesthesia
- Subject has Raynaud's disease
- Subject has unacceptable collateral circulation based on investigator exam
- Subject is pregnant, lactating, or trying to get pregnant
- Subject is unable or unwilling to provide informed consent or comply with study procedures
- Subject has any other condition making them unsuitable for the study according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hypoxia Research Laboratory
San Francisco, California, United States, 94133
Actively Recruiting
Research Team
K
Kim Tompkins
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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