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Pressure Sensing to Reduce the Risk of Pressure Ulcer Formation

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ClinicalTrials.gov Identifier: NCT02325388
Recruitment Status : Recruiting
First Posted : December 25, 2014
Last Update Posted : October 13, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Pressure Ulcer Device: ForeSite PT™ system

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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 Start Date : December 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
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.
No Intervention: 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.


Outcome Measures

Primary Outcome Measures :
  1. Interface pressure analysis - peak pressure [ Time Frame: 72 hours ]
    Peak pressure of any given pressure reading sample

  2. Interface pressure analysis - sensel pressure reading [ Time Frame: 72 hours ]
    Absolute number of sensels with pressure readings greater than 40 mmHg

  3. Interface pressure analysis - average pressure [ Time Frame: 72 hours ]
    Average interface pressure (excluding sensels with 0mmHg reading)

  4. Interface pressure analysis - % with pressure over 40mmHg [ Time Frame: 72 hours ]
    Proportion of participants that have pressure readings greater than 40 mmHg


Secondary Outcome Measures :
  1. Pressure related skin and soft tissue changes [ Time Frame: 72 hours ]
    Any change in the skin appearance, pressure ulcer formation, skin/wound infection

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325388


Contacts
Contact: Wrechelle Ocampo wbocampo@ucalgary.ca
Contact: Jaime Kaufman, PhD jbjarnso@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Ward of the 21st Century
Alberta Innovates Health Solutions
Investigators
Principal Investigator: Chester H Ho, MD University of Calgary
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chester Ho, MD, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02325388     History of Changes
Other Study ID Numbers: REB13-0794
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chester Ho, MD, University of Calgary:
pressure ulcer
decubitus ulcer
bed sore
continuous pressure mapping
interface pressure imaging

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases