Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation

NCT ID: NCT02325388

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 678 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-05-10

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.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ForeSite PT™ system

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

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

Sponsors

Ward of the 21st Century

OTHER

Sponsor Role: collaborator

Alberta Innovates Health Solutions

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Chester Ho, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chester H Ho, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

References

Ho C, Ocampo W, Southern DA, Sola D, Baylis B, Conly JM, Hogan DB, Kaufman J, Stelfox HT, Ghali WA. Effect of a Continuous Bedside Pressure Mapping System for Reducing Interface Pressures: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316480. doi: 10.1001/jamanetworkopen.2023.16480.

Reference Type: DERIVED

PMID: 37266939 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26420303 (View on PubMed)

Other Identifiers

REB13-0794

Identifier Type: -

Identifier Source: org_study_id