Clinical Trial: Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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-
Brief Summary: Pressure ulcers are prevalent conditions that result in substantial financial costs to the healthcare system as well as significant distress to affected patients and their families. This study is a parallel two-group randomized controlled trial that aims to study how the use of a pressure sensing device with continuous visual feedback of pressure imaging may potentially decrease the interface pressure of patients who are at risk of pressure ulcers in an acute hospital setting.
Detailed Summary:
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 bas
Sponsor: University of Calgary
Current Primary Outcome:
- Interface pressure analysis [ Time Frame: 72 hours ]Peak pressure of any given pressure reading sample
- Interface pressure analysis [ Time Frame: 72 hours ]Absolute number of sensels with pressure readings greater than 40 mmHg
- Interface pressure analysis [ Time Frame: 72 hours ]Average interface pressure (excluding sensels with 0mmHg reading)
- Interface pressure analysis [ Time Frame: 72 hours ]Proportion of participants that have pressure readings greater than 40 mmHg
Original Primary Outcome:
- Interface pressure analysis [ Time Frame: 72 hours ]Proportion of participants that have pressure readings greater than 40 mmHg
- Interface pressure analysis [ Time Frame: 72 hours ]Average interface pressure (excluding sensels with 0mmHg reading).
- Interface pressure analysis [ Time Frame: 72 hours ]Absolute number of sensels with pressure readings greater than 40 mmHg.
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: University of Calgary
Dates:
Date Received: December 17, 2014
Date Started: December 2014
Date Completion: March 2018
Last Updated: August 23, 2016
Last Verified: August 2016
