Pressure Ulcer Monitoring Platform (PUMP)

Not Applicable

Completed

• Conditions: Pressure Ulcer
• Interventions: Behavioral: PUMP Monitoring

• Registration Number: NCT02952664
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-02
• Study Start: 2017-01
• Status Verified: 2017-07
• Primary Completion: 2017-07-06
• Study Completion: 2017-07-06
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PUMP Monitoring	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

Name	Time	Method
Comparison of sensor output with video-recorded data	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.

Trial Locations

Locations (1)

UPMC Mercy; 🇺🇸 Pittsburgh, Pennsylvania, United States