Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Protocol is being reevaluated by sponsor
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zephyr BioPatch | Device | The ZephyrLIFE Hospital System includes the BioPatchâ„¢ device (consisting of the BioModuleâ„¢ sensor, BioModuleâ„¢ holder, and snap ECG electrodes), the ECHO radio system, and a software monitoring interface. The BioModuleâ„¢ 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. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria for Laboratory Subject:
Exclusion Criteria for Laboratory Subject:
Inclusion Criteria for Hospital Subjects:
Exclusion Criteria for Hospital Subjects:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason Adelman, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
Not provided
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided