Actively Recruiting
Accuracy of the Evie 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
Researchers are evaluating the accuracy of the EvieMED Ring Pulse Oximeter in measuring oxygen saturation levels between 70% and 100% during profound hypoxia. This observational study compares the pulse oximeter readings to arterial blood samples and hospital-grade reference devices in healthy adult volunteers. The goal is to assess the performance of multiple test devices under controlled conditions involving both motion and rest. During the study, four test pulse oximeter rings were placed on the finger bases and fingertips, with some devices kept in motion and others motionless. Additional devices were worn on the contralateral hand and wrist. Hypoxemia was induced by having subjects breathe controlled mixtures of nitrogen, air, and carbon dioxide, with oxygen saturation levels maintained at stable plateaus for measurement. Arterial blood samples and pulse oximeter readings were collected at each plateau to compare accuracy. Participants will have a radial arterial cannula placed for blood sampling and blood pressure monitoring. Their hands with test devices will be kept either moving or still during the testing. Researchers will record oxygen saturation accuracy over two days, along with demographic data and skin color assessment. The total participation involves testing hypoxia responses, with measurements compared to determine the test devices' accuracy.
CONDITIONS
Brief 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
- Adult aged 18 to 49 years
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 sensor sites
- Subject has a history of fainting or vasovagal response
- Subject has a sensitivity to local anesthesia
- Subject has Raynaud's disease
- Subject has unacceptable collateral circulation
- 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have pulse oximeter devices placed on their fingers and wrist for measurement. Blood samples are taken through a radial arterial cannula while participants breathe controlled gas mixtures to induce different levels of oxygen saturation.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Hypoxia Research Laboratory
San Francisco, California, United States, 94133
Actively Recruiting
Research Team
K
Kim Tompkins
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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