27
Participants
Start Date
June 25, 2019
Primary Completion Date
July 25, 2019
Study Completion Date
July 25, 2019
Measurement of respiratory rate with DUT and comparison with reference
"The subject will follow the paced breathing app, once a stable Respiration Rate at the natural rate (without the breathing app) is captured. The breathing pattern on the app will be set to begin near the normal Respiration Rate of the subject and continue to go down by five intervals until reaching the Respiration Rate of 5 bpm. After that, we will pick back up at the rate above the subject's normal Respiration Rate and continue upwards until reaching 50 bpm or as high as the subject can tolerate up to 50 bpm.~The respiratory rate will be monitored simultaneously with an EtCo2 (Reference) and the BORA BAND™ wristband monitoring system, Device Under Test. These data will be continuously recorded electronically. Additional study notes that describe conditions of the test as well as deviations, device issues and any adverse events will be recorded in written documentation."
Clinimark Laboratory, Louisville
Lead Sponsor
Clinimark, LLC
OTHER
Biosency
INDUSTRY