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

April 4, 2017 updated by: Medtronic - MITG
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York City, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body position
Time Frame: During a 2.5 hour lab observation
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
Time Frame: 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).
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)
Time Frame: 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).
During a 24 hospital observation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVMOPO0520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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