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Pressure Ulcer Monitoring Platform (PUMP) (PUMP)

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PUMP Monitoring
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is over 18 years of age
  • Subject is immobile and/or unable to independently re-position self

Exclusion Criteria:

  • Subject is under the age of 18 years
  • Subject is able to independently re-position self

Sites / Locations

  • UPMC Mercy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PUMP Monitoring

Arm Description

A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video.

Outcomes

Primary Outcome Measures

Comparison of sensor output with video-recorded data
The dependent variables evaluated in this study are the measured outcomes as recorded by the devices and the signals collected from the accelerometer and gyroscope within said devices; the independent variable to be evaluated in this study is patient movement.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2016
Last Updated
July 13, 2017
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02952664
Brief Title
Pressure Ulcer Monitoring Platform (PUMP)
Acronym
PUMP
Official Title
Pressure Ulcer Monitoring Platform (PUMP): A Device to Monitor Patient Positioning
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will employ two monitoring device prototypes. The devices are sensors containing accelerometers and gyroscope. The raw output data will be analyzed to determine when patients are moved or are repositioned in their beds. The data is captured within a modem which will correlate these movements with video recordings for interpretation by the research team. One sensor is wearable on the patient gown or sleepwear, and the other is placed underneath the frame of the hospital bed. The investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. The goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials.
Detailed Description
The investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. The goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials. The repositioning events recorded by the sensor devices will be automatically uploaded and abstracted by the research team, along with the events captured by the simultaneous video recording of patient repositioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PUMP Monitoring
Arm Type
Experimental
Arm Description
A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video.
Intervention Type
Behavioral
Intervention Name(s)
PUMP Monitoring
Intervention Description
A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video.
Primary Outcome Measure Information:
Title
Comparison of sensor output with video-recorded data
Description
The dependent variables evaluated in this study are the measured outcomes as recorded by the devices and the signals collected from the accelerometer and gyroscope within said devices; the independent variable to be evaluated in this study is patient movement.
Time Frame
10 hours of monitoring

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is over 18 years of age Subject is immobile and/or unable to independently re-position self Exclusion Criteria: Subject is under the age of 18 years Subject is able to independently re-position self
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patsy Simon, RN,BS,CCRC
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joseph P Rubin, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Mercy
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pressure Ulcer Monitoring Platform (PUMP)

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