Pressure Ulcer Monitoring Platform (PUMP)

Pressure Ulcer Clinical Trial

— PUMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952664
• Other study ID #: UPittsburghCCA
• Status: Completed
• Phase: N/A
• First received: October 26, 2016
• Last updated: July 13, 2017
• Start date: January 2017
• Est. completion date: July 6, 2017

Study information

• Verified date: July 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 6, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Mercy	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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