Pressure Ulcer Monitoring Platform (PUMP)

NCT ID: NCT02952664

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-07-06

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.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PUMP Monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

J. Peter Rubin, MD

Endowed Professor and Chair of Plastic Surgery, Professor of Bioengineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patsy Simon, RN,BS,CCRC

Role: STUDY_DIRECTOR

University of Pittsburgh

Joseph P Rubin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Mercy

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

UPittsburghCCA

Identifier Type: -

Identifier Source: org_study_id