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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Patient Positioning Monitoring, Physiologic Pressure Ulcer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ZephyrLIFE Hospital System

Eligibility Criteria

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Inclusion Criteria

1. Signed and dated informed consent by subject
2. Male or female of any race
3. At least 18 years of age
4. Willingness to have study device attached during study participation
5. Willingness to participate in all aspects of the study

1. Signed and dated informed consent by subject
2. Male or female of any race
3. At least 18 years of age
4. Expected hospitalized admission on the general care floor for at least three days
5. At risk for hospital-acquired pressure ulcers as defined by score on the Braden Scale of \< 18
6. Willingness to have study devices attached during study participation
7. Willingness to participate in all aspects of the study

Exclusion Criteria

1. Implanted pacemaker or defibrillator
2. Allergy or sensitivity to ECG leads or similar types of adhesive
3. History of hospital admission or a surgical procedure in the 60 days prior to study enrollment
4. BMI \> 30.0

1. Implanted pacemaker or defibrillator
2. Allergy or sensitivity to ECG leads or similar types of adhesive
3. Subject will be sleeping in a chair or spending the majority of time in a chair
4. BMI \> 39.9

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes