Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation

NCT02325388 | Completed

• 1 other identifier: REB13-0794
• Study Type: interventional
• Target: 678
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

pressure ulcer; decubitus ulcer; bed sore; continuous pressure mapping; interface pressure imaging

Outcome Measures

Primary Outcomes (4)

• Interface pressure analysis - peak pressure

  Peak pressure of any given pressure reading sample

  72 hours

• Interface pressure analysis - sensel pressure reading

  Absolute number of sensels with pressure readings greater than 40 mmHg

  72 hours

• Interface pressure analysis - average pressure

  Average interface pressure (excluding sensels with 0mmHg reading)

  72 hours

• Interface pressure analysis - % with pressure over 40mmHg

  Proportion of participants that have pressure readings greater than 40 mmHg

  72 hours

Secondary Outcomes (3)

• Pressure related skin and soft tissue changes

  72 hours

• Perceptions of healthcare providers

  72 hours

• Perceptions of patients

  72 hours

Study Arms (2)

Treatment group with ForeSite PT™ system

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

ForeSite PT™ system 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.

Treatment group with ForeSite PT™ system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Unable (score of "0") to bridge, roll onto their side, and sit from lying supine.
• Unable (score of "0") to bridge and roll onto their side, and requires minimal assistance and/or supervision with sitting from lying supine.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Ward of the 21st Century: collaborator
• Alberta Innovates Health Solutions: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

Location

Related Publications (2)

• 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.

  PMID: 37266939 DERIVED

• 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.

  PMID: 26420303 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chester H Ho, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 25, 2014
• Study Start: December 1, 2014
• Primary Completion: May 7, 2018
• Study Completion: May 10, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

CA (1)