Clinical trial NCT02548624: An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position
Official title: An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Patient Positioning
Monitoring, Physiologic
Pressure Ulcer
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The laboratory observation will consist of one non-patient subject (N=1). The hospital observation will consist of 18 patients (N=18) hospitalized at the Columbia University Medical Center on the general care floor at-risk for hospital-acquired pressure ulcers. The hospitalized subjects will be stratified into three groups. Six subjects with normal BMI classification (18.5 -24.9), six with overweight BMI classification (25.0-29.9), and six with overweight BMI classification (30.0-39.9) will comprise the study sample.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Body position
timeFrame: During a 2.5 hour lab observation
measure: Body position
timeFrame: During a 24 hospital observation
Secondary outcomes:
measure: Performance of the Zephyr BioPatch position output in hospitalized patients of varying body mass indexes (BMI)
timeFrame: During a 24 hospital observation.
Other outcomes:
Locations:
city: New York City
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jason Adelman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: