Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2023-02-28
2023-03-01
Brief Summary
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A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Healthy Adults
Healthy adults
Mixtures of nitrogen, air, and carbon dioxide
Hypoxia was induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2 displayed on a screen using LabVIEW 2015
Interventions
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Mixtures of nitrogen, air, and carbon dioxide
Hypoxia was induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2 displayed on a screen using LabVIEW 2015
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal hemoglobin levels (Hemoglobin \> 10 g/dL)
Exclusion Criteria
* Obesity
21 Years
50 Years
ALL
Yes
Sponsors
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Gabi SmartCare
INDUSTRY
Responsible Party
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Principal Investigators
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Philip E Bickler, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Hypoxia Research Laboratory
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SpO2_3
Identifier Type: -
Identifier Source: org_study_id