NCT02548624

An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Patient Positioning
• Monitoring, Physiologic
• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	Zephyr BioPatch	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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-09-14
• Last updated: 2017-04-06

Locations

1 site across 1 country: United States