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

Medtronic

Status: Withdrawn

Conditions: Patient Positioning; Pressure Ulcer; Monitoring, Physiologic

Treatments: Device: Zephyr BioPatch

Study type: Observational

Funder types: Industry

Identifiers

NCT02548624

COVMOPO0520

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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