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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patient Positioning, Monitoring, Physiologic, Pressure Ulcer

Intervention / Treatment
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* Device: Zephyr BioPatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Laboratory Subject: Signed and dated informed consent by subject Male or female of any race At least 18 years of age Willingness to have study device attached during study participation Willingness to participate in all aspects of the study Exclusion Criteria for Laboratory Subject: Implanted pacemaker or defibrillator Allergy or sensitivity to ECG leads or similar types of adhesive History of hospital admission or a surgical procedure in the 60 days prior to study enrollment BMI > 30.0 Inclusion Criteria for Hospital Subjects: Signed and dated informed consent by subject Male or female of any race At least 18 years of age Expected hospitalized admission on the general care floor for at least three days At risk for hospital-acquired pressure ulcers as defined by score on the Braden Scale of < 18 Willingness to have study devices attached during study participation Willingness to participate in all aspects of the study Exclusion Criteria for Hospital Subjects: Implanted pacemaker or defibrillator Allergy or sensitivity to ECG leads or similar types of adhesive Subject will be sleeping in a chair or spending the majority of time in a chair BMI > 39.9

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Zephyr 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |