Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation

Pressure Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325388
• Other study ID #: REB13-0794
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: May 10, 2018

Study information

• Verified date: May 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: May 10, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Alberta Innovates Health Solutions, Ward of the 21st Century

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interface pressure analysis - peak pressure	Peak pressure of any given pressure reading sample	72 hours
Primary	Interface pressure analysis - sensel pressure reading	Absolute number of sensels with pressure readings greater than 40 mmHg	72 hours
Primary	Interface pressure analysis - average pressure	Average interface pressure (excluding sensels with 0mmHg reading)	72 hours
Primary	Interface pressure analysis - % with pressure over 40mmHg	Proportion of participants that have pressure readings greater than 40 mmHg	72 hours
Secondary	Pressure related skin and soft tissue changes	Any change in the skin appearance, pressure ulcer formation, skin/wound infection	72 hours
Secondary	Perceptions of healthcare providers	Survey of healthcare providers on prior experience with pressure mapping technology, functionality, ease of use, and interpretation of pressure data on the LCD monitor.	72 hours
Secondary	Perceptions of patients	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.	72 hours