The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients.
Study Type
OBSERVATIONAL
The ZephyrLIFE Hospital System includes the BioPatch™ device (consisting of the BioModule™ sensor, BioModule™ holder, and snap ECG electrodes), the ECHO radio system, and a software monitoring interface. The BioModule™ sensor is a Class II device, 510(k) cleared by the FDA, and commercially available. The ZephyrLIFE Hospital System stores, transmits and displays vital sign data including ECG, HR, RR, body orientation, and activity to caregivers via a central station.
Columbia University Medical Center
New York, New York, United States
Body position
Body position will be classified as facing right, facing left, facing down (prone), or facing up (supine).
Time frame: During a 2.5 hour lab observation
Body position
Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).
Time frame: During a 24 hospital observation
Performance of the Zephyr BioPatch position output in hospitalized patients of varying body mass indexes (BMI)
Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).
Time frame: During a 24 hospital observation.
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