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



Status:Suspended
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2016
End Date:February 2017

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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.


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
We found this trial at
1
site
New York City, New York 10032
?
mi
from
New York City, NY
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