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Trial record 1 of 1 for:    Pressure Ulcer Monitoring Platform (PUMP)
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Pressure Ulcer Monitoring Platform (PUMP) (PUMP)

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952664


Locations
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United States, Pennsylvania
UPMC Mercy
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Study Director: Patsy Simon, RN,BS,CCRC University of Pittsburgh
Principal Investigator: Joseph P Rubin, MD University of Pittsburgh
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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    Key Record Dates
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:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases