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OpenTrials
Completed

NCT Number: NCT02952664

Pressure Ulcer Monitoring Platform (PUMP)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Mercy

Pittsburgh, Pennsylvania, 15224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Pressure Ulcer Monitoring Platform (PUMP): A Device to Monitor Patient Positioning

Acronym: PUMP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2016
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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