In Vivo Pulse Oximeter Validation Study (NCT05873335) | Clinical Trial Compass
CompletedNot Applicable
In Vivo Pulse Oximeter Validation Study
United States12 participantsStarted 2023-02-28
Plain-language summary
The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device
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.
Who can participate
Age range
21 Years – 50 Years
Sex
ALL
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