Status:
COMPLETED
Accuracy of Pulse Oximeters With Profound Hypoxia at Rest
Lead Sponsor:
Nihon Kohden
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Hypoxia
Eligibility:
All Genders
18-50 years
Brief Summary
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling....
Detailed Description
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submissi...
Eligibility Criteria
Inclusion
- Both male and female subjects who can give written informed consent
- Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
- Meeting the demographic requirements
Exclusion
- Age below 18 or over 50
- Pregnant women
- Significant arrhythmia
- Blood pressure above 150 systolic or 90 diastolic
- Carboxyhemoglobin levels over 3%
- Subjects whom the investigator consider ineligible for the study
Key Trial Info
Start Date :
March 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04814823
Start Date
March 24 2021
End Date
February 15 2022
Last Update
September 12 2025
Active Locations (1)
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1
UCSF Hypoxia Research Laboratory
San Francisco, California, United States, 94133