Pressure Ulcer Monitoring Platform (PUMP)

NCT02952664 | Completed

• 1 other identifier: UPittsburghCCA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  10 hours of monitoring

Study Arms (1)

PUMP Monitoring

EXPERIMENTAL

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.

Behavioral: PUMP Monitoring

Interventions

PUMP Monitoring BEHAVIORAL

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.

PUMP Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Mercy

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patsy Simon, RN,BS,CCRC

  University of Pittsburgh

  STUDY DIRECTOR

• Joseph P Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endowed Professor and Chair of Plastic Surgery, Professor of Bioengineering

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 2, 2016
• Study Start: January 1, 2017
• Primary Completion: July 6, 2017
• Study Completion: July 6, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

US (1)