Clinical trial NCT02325388: Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: pressure ulcer
decubitus ulcer
bed sore
continuous pressure mapping
interface pressure imaging
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Ward of the 21st Century
name: Alberta Innovates Health Solutions
First posted: 2014-12-25
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult, man or woman, with a minimum age limit of 18 years old.
* Expected to have a length of stay on the unit of at least three days.
* Require assistance with bed mobility or completely dependent for bed mobility as determined by the "Bed" components in the de Morton Mobility Index (DEMMI). Eligible patients would be:

  1. Unable (score of "0") to bridge, roll onto their side, and sit from lying supine.
  2. Unable (score of "0") to bridge and roll onto their side, and requires minimal assistance and/or supervision with sitting from lying supine.
  3. Able (score of "1") to bridge, unable to roll onto their side (score of "0"), and requires minimal assistance and/or supervision with sitting from lying supine.
* Capacity to provide consent, or have a surrogate decision-maker provide consent on their behalf.
* Not near the end of life within three days of enrolment in the study.

Exclusion Criteria:

* Have a planned admission to another unit (including those identified as a setting for data collection in the study) within three days of enrolment in the study.
* Sleep in a chair at night.
* Whose clinical care would be negatively impacted if turned or repositioned.

Primary outcomes:
measure: Interface pressure analysis - peak pressure
timeFrame: 72 hours
measure: Interface pressure analysis - sensel pressure reading
timeFrame: 72 hours
measure: Interface pressure analysis - average pressure
timeFrame: 72 hours
measure: Interface pressure analysis - % with pressure over 40mmHg
timeFrame: 72 hours
Secondary outcomes:
measure: Pressure related skin and soft tissue changes
timeFrame: 72 hours
measure: Perceptions of healthcare providers
timeFrame: 72 hours
measure: Perceptions of patients
timeFrame: 72 hours
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Chester H Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong H, Kaufman J, Baylis B, Conly JM, Hogan DB, Stelfox HT, Southern DA, Ghali WA, Ho CH. Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial. Trials. 2015 Sep 29;16:434. doi: 10.1186/s13063-015-0949-x.