Monitoring, Physiologic, Patient Positioning, Pressure Ulcer
Conditions
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.
Interventions
DEVICEZephyr 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.
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body position | During a 2.5 hour lab observation | Body position will be classified as facing right, facing left, facing down (prone), or facing up (supine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the Zephyr BioPatch position output in hospitalized patients of varying body mass indexes (BMI) | During a 24 hospital observation. | Body position when lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine). |
Countries
United States
Outcome results
None listed