Pressure Ulcer Clinical Trial
Official title:
An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position
Verified date | April 2017 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York City | New York |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
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. |
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