Pressure Ulcer Monitoring Platform (PUMP) (PUMP)

• ClinicalTrials.gov Identifier: NCT02952664
• Recruitment Status: Completed
• First Posted: November 2, 2016
• Last Update Posted: July 18, 2017
• Sponsor: University of Pittsburgh
• Information provided by (Responsible Party): J. Peter Rubin, MD, University of Pittsburgh

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.

Condition or disease	Intervention/treatment	Phase
Pressure Ulcer	Behavioral: PUMP Monitoring	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Pressure Ulcer Monitoring Platform (PUMP): A Device to Monitor Patient Positioning
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: July 6, 2017
• Actual Study Completion Date: July 6, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: PUMP Monitoring; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Comparison of sensor output with video-recorded data [ Time Frame: 10 hours of monitoring ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

UPMC Mercy

Pittsburgh, Pennsylvania, United States, 15224

Sponsors and Collaborators

University of Pittsburgh

Investigators

• Study Director: Patsy Simon, RN,BS,CCRC; University of Pittsburgh
• Principal Investigator: Joseph P Rubin, MD; University of Pittsburgh

More Information

• Responsible Party: J. Peter Rubin, MD, Endowed Professor and Chair of Plastic Surgery, Professor of Bioengineering, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02952664
• Other Study ID Numbers: UPittsburghCCA
• First Posted: November 2, 2016
• Last Update Posted: July 18, 2017
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Pressure Ulcer; Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases