Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02325388|
Recruitment Status : Recruiting
First Posted : December 25, 2014
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer||Device: ForeSite PT™ system||Not Applicable|
Background: Pressure ulcers result in substantial financial costs to the healthcare system as well as significant distress to affected patients and their families. As interface pressure is a key risk factor in the development of pressure ulcers, continuous visual feedback of continuous pressure imaging (CPI) between the body and support surface could inform healthcare providers on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers. This randomized, controlled trial aims to study the effect of CPI on the reduction of interface pressure, and the incidence of pressure ulcers in vulnerable hospital patients.
Methods: A parallel two-group randomized controlled clinical trial will be conducted. A total of 678 eligible consenting inpatients at high risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either have the ForeSite PT™ system with the liquid-crystal display ("LCD") monitor turned on to provide visual feedback through CPI to healthcare providers while also collecting continuous interface pressure data (intervention group), or have the ForeSite PT™ system with the LCD monitor turned off, therefore not providing visual feedback or CPI to healthcare providers, while collecting continuous interface pressure data in the background (control group), in a ratio of 1:1. Data will be collected on both groups for three days (72 hours). The primary outcome will be the differences in the two groups' interface pressure analysis. The interface pressure readings will be collected through hourly sampling of continuous interface pressure recordings taken throughout this study period. Clinical outcomes will be the differences in the two groups' pressure-related skin and soft tissue change in areas at risk of pressure ulcer. It will be obtained at baseline (within 24 hours of admission) and on the third day of the trial. Perceptions of intervention patients and healthcare providers will be obtained on the third day.
Discussion: This will be the first randomized controlled trial to investigate the effect of CPI on interface pressure of vulnerable hospital patients, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||678 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of a Pressure-sensing System to Reduce the Risk of Pressure Ulcer Formation by Lowering Interface Pressure in Vulnerable Patient Populations: A Parallel-two-group Randomized Controlled Trial|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: Treatment group with ForeSite PT™ system
Inpatients assigned to the treatment group with the ForeSite PT™ system will have its LCD monitor turned on (i.e., real-time images of interface pressure will be displayed on the monitor) during their enrolment in the trial.
Device: ForeSite PT™ system
XSENSOR Technology Corporation's ForeSite PT™ Patient Turn System (referred to as the "ForeSite PT™ system") continuously monitors interface pressure and provides CPI that quantifies real-time interface pressure information. It also provides patient turn tracking to assist with management of the patient turn schedule by alerting healthcare providers and/or caregivers to the location of body areas that have experienced the greatest exposure, and when the next turn/repositioning is due as per pre-set alerts.
No Intervention: Control group
Inpatients assigned to the control group will have the ForeSite PT™ system's LCD monitor turned off and hidden (i.e., real-time images of interface pressure will not be displayed on the monitor). As the ForeSite PT™ system will continue to record interface pressure with the display turned off, this enables patients enrolled in the control group to undergo silent monitoring.
- Interface pressure analysis - peak pressure [ Time Frame: 72 hours ]Peak pressure of any given pressure reading sample
- Interface pressure analysis - sensel pressure reading [ Time Frame: 72 hours ]Absolute number of sensels with pressure readings greater than 40 mmHg
- Interface pressure analysis - average pressure [ Time Frame: 72 hours ]Average interface pressure (excluding sensels with 0mmHg reading)
- Interface pressure analysis - % with pressure over 40mmHg [ Time Frame: 72 hours ]Proportion of participants that have pressure readings greater than 40 mmHg
- Pressure related skin and soft tissue changes [ Time Frame: 72 hours ]Any change in the skin appearance, pressure ulcer formation, skin/wound infection
- Perceptions of healthcare providers [ Time Frame: 72 hours ]Survey of healthcare providers on prior experience with pressure mapping technology, functionality, ease of use, and interpretation of pressure data on the LCD monitor.
- Perceptions of patients [ Time Frame: 72 hours ]Survey of patients on prior and current experience with CPI (including sensor mattress cover and monitor display of their pressure distribution) on their care and comfort.
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): NCT02325388
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada|
|Principal Investigator:||Chester H Ho, MD||University of Calgary|