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

Withdrawn

• Conditions: Pressure Ulcer; Patient Positioning; Monitoring, Physiologic

• Registration Number: NCT02548624
• Lead Sponsor: Medtronic - MITG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Study Start: 2016-11
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body position	During a 24 hospital observation	Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).

Secondary Outcome Measures

Name	Time	Method
Performance of the Zephyr BioPatch position output in hospitalized patients of varying body mass indexes (BMI)	During a 24 hospital observation.	Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York City, New York, United States