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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02548624
• Other study ID #: COVMOPO0520
• Status: Withdrawn
• Phase: N/A
• First received: September 1, 2015
• Last updated: April 4, 2017
• Start date: November 2016
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Laboratory Subject:

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

Exclusion Criteria for Laboratory Subject:

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

Inclusion Criteria for Hospital Subjects:

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 for Hospital Subjects:

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

Related Conditions & MeSH terms

• Monitoring, Physiologic
• Patient Positioning
• Pressure Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body position	Body position will be classified as facing right, facing left, facing down (prone), or facing up (supine).	During a 2.5 hour lab observation
Primary	Body position	Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).	During a 24 hospital observation
Secondary	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).	During a 24 hospital observation.