Wearing Comfort Clinical Trial
Official title:
Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the ears and on the face skin, the cannula itself (especially in the nostrils and the mouth surrounding) and the smell.
This test compares 4 models for the duration of up to 3 days each and 2 models with duration
of up to 24 hours. Each subject will tested the models and will provide feedback at
predefined times during the test. During the test and according to initial result the team
may decide to shorten the test duration.
The testing staff will include a dermatologist and a technical representative that will
supervise the test in order to monitor and control the required performance of the subjects
according to test protocol, and relevant outcomes. During the test the dermatologist will
monitor any unexpected skin reaction or patient discomfort.
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