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

NCT02548624 | Withdrawn

• 1 other identifier: COVMOPO0520
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Positioning; Monitoring, Physiologic; Pressure Ulcer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Performance of the Zephyr BioPatch position output in hospitalized patients of varying body mass indexes (BMI)

  During a 24 hospital observation.

Interventions

Zephyr BioPatch DEVICE

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.

Also known as: ZephyrLIFE Hospital System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jason Adelman, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 14, 2015
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (1)