search
Back to results

Implementation and Evaluation of CBPM Technology (CBPM)

Primary Purpose

Pressure Injury, Surgical Wound

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ForeSite Intelligent Surface
Sponsored by
Barry Baylis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pressure Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For evidence of skin breakdown:

Inclusion Criteria:

  • adults that require assistance with bed mobility or are entirely dependent for bed mobility based on de Morton Mobility Index, ability to provide consent or have a legal representative to provide consent on their behalf, expected length of stay is more than 14 days

Exclusion Criteria:

  • near end of life, have a planned admission to another unit, their clinical care would be negatively impacted if turned or repositioned, increased mobility

For post-surgical repair:

Inclusion Criteria:

  • adults, flap repair where the donor or recipient site is on the posterior side of the patient, or trauma patients with a surgical procedure on the posterior side of the patient, ability to provide consent or have a legal representative to provide consent on their behalf, partially or entirely dependent on mobility for the first 14-21 days post-surgery, ALOS is over 14 days

Exclusion Criteria:

  • a patient has complications that result in near end of life with death imminent, the patient becomes more mobile (e.g., can sit up from supine without assistance or can roll to the side without assistance) in less than 14 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Prospective

    Arm Description

    Participants will be monitored by the ForeSite Intelligent Surface system for 2-3 weeks.

    Outcomes

    Primary Outcome Measures

    Incorporating the ForeSite IS in nursing care
    Compliance of repositioning patients according to the system and recommended turning regimen by clinician, and feedback from nursing staff during focus groups
    Providing evidence of skin breakdown
    Incidence of pressure injuries and skin assessments correlated to average interface pressure, average pressure exposure and peak pressure
    Improves healing of surgical wounds
    Skin and surgical site infections correlated to average interface pressure, average pressure exposure and peak pressure

    Secondary Outcome Measures

    Improving nursing workflow
    rate of repositioning per day, average exposure time between repositions and duration of body positions
    Cost-effectiveness
    cost of care per quality adjusted life year

    Full Information

    First Posted
    May 2, 2022
    Last Updated
    May 2, 2022
    Sponsor
    Barry Baylis
    Collaborators
    XSENSOR Technology Corporation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05363475
    Brief Title
    Implementation and Evaluation of CBPM Technology
    Acronym
    CBPM
    Official Title
    Implementation and Evaluation of a Continuous Bedside Pressure Mapping System in Multiple Patient Care Settings
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    December 15, 2022 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Barry Baylis
    Collaborators
    XSENSOR Technology Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background & Rationale: Pressure injuries are costly to treat and are prevalent in about 26% of patients across all healthcare settings in Canada. Wounds Canada has developed recommendations for prevention and management to tackle this problem that include pressure injury risk assessment, pressure relief surfaces, nutrition, wound monitoring, and wound care. Continuous bedside pressure mapping (CBPM) technology can assist with effective repositioning of patients to prevent pressure injuries. The ForeSite Intelligent Surface system (ForeSite IS) is a CBPM technology that uses machine learning and artificial intelligent software for more intuitive repositioning of patients. Various studies have shown the technology to be effective in reducing pressure injuries and providing adequate pressure redistribution for patients with a PI flap reconstruction. Furthermore, some studies have indicated the device's cost savings, but there are no known publications on cost-effectiveness. Despite the few studies evaluating CBPM technology, few have implemented it in nursing care. Particularly in Canada, there are no guidelines for incorporating CBPM technology into pressure injury prevention care plans or post-surgical recovery in any healthcare setting. Research Question and Objectives: In this study we will be piloting the ForeSite IS system in long-term care, acute care, plastic surgery and trauma patients to further identify the benefits of utilizing the device and evaluate its implementation. The primary objectives are: To determine if the ForeSite IS system can be incorporated in improving quality of care for at risk patients by providing continuous skin exposure monitoring To determine if the ForeSite IS system can provide evidence of skin breakdown to reduce the incidence and risk of PIs To determine if the ForeSite IS system can assist with offloading of pressure to improve healing of post-surgical patients The secondary objectives are: To determine if the device improves nursing workflow and productivity To determine the cost-effectiveness of using the ForeSite IS system Methods: The ForeSite IS system will be piloted in long-term care and acute care for six months. The researchers will identify patients with nursing staff and get permission to approach them. Once permitted, they will explain the study and obtain written consent from patients who agree to participate. Nursing staff will be responsible for setting up and removing the device from the patient's bed. For the first 48 hours of monitoring with the device, no visual feedback (blinded period) will be provided to the nursing staff to collect interface pressure and patient repositioning data on current care practices. Nursing staff will then have another 48 hours to use the visual feedback from the device and acclimatize to the device (acclimatization period). Afterwards, nursing staff will use the visual feedback for the remainder of the patient's two to three weeks of monitoring (active period), depending on the clinical setting. Nurses will continue with routine skin assessments throughout the entire monitoring with additional skin assessments if prompted by the visual feedback during the active period. Interface pressure and patient repositioning in the first 48-hour blinded period will be compared to the monitoring period after the 48-hour acclimatization period. After implementation of the pilot, clinical outcomes will be compared to clinical outcomes of a six-month period prior to the pilot. Pre-implementation focus groups/interviews will be conducted with nursing staff to help each clinical setting develop a protocol for using the ForeSite IS system and develop strategies for implementation. Post-implementation focus groups/interviews will be conducted one to two months after implementation of the system to understand the system's barriers, facilitators, and sustainability aspects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure Injury, Surgical Wound

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective cohort with comparison to retrospective cohort
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prospective
    Arm Type
    Experimental
    Arm Description
    Participants will be monitored by the ForeSite Intelligent Surface system for 2-3 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    ForeSite Intelligent Surface
    Other Intervention Name(s)
    ForeSite IS
    Intervention Description
    The ForeSite IS is a continuous bedside pressure mapping system with machine learning and artificial intelligence (ML/AI). It consists of an overlay with over 1500 undetectable integrated sensors and a medical-grade bedside touchscreen monitor. The monitor displays a real-time coloured body pressure image, a turn timer, and a history of previous turns. The ML/AI software tracks 17 body locations and the patient's body position. The system has a centralized dashboard that shows the pressure injury risk and turn history, which can be transmitted to the nursing station. In addition, data is stored in an Amazon Web Services (AWS) secured cloud database, enabling access to individual reports on turn history and compliance and pressure exposure. Data is stored as both, raw pressure data files and real time event information on pressure exposure and turn data.
    Primary Outcome Measure Information:
    Title
    Incorporating the ForeSite IS in nursing care
    Description
    Compliance of repositioning patients according to the system and recommended turning regimen by clinician, and feedback from nursing staff during focus groups
    Time Frame
    2-3 weeks during monitoring
    Title
    Providing evidence of skin breakdown
    Description
    Incidence of pressure injuries and skin assessments correlated to average interface pressure, average pressure exposure and peak pressure
    Time Frame
    2 weeks during monitoring
    Title
    Improves healing of surgical wounds
    Description
    Skin and surgical site infections correlated to average interface pressure, average pressure exposure and peak pressure
    Time Frame
    2-3 weeks during monitoring
    Secondary Outcome Measure Information:
    Title
    Improving nursing workflow
    Description
    rate of repositioning per day, average exposure time between repositions and duration of body positions
    Time Frame
    2-3 weeks
    Title
    Cost-effectiveness
    Description
    cost of care per quality adjusted life year
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    For evidence of skin breakdown: Inclusion Criteria: adults that require assistance with bed mobility or are entirely dependent for bed mobility based on de Morton Mobility Index, ability to provide consent or have a legal representative to provide consent on their behalf, expected length of stay is more than 14 days Exclusion Criteria: near end of life, have a planned admission to another unit, their clinical care would be negatively impacted if turned or repositioned, increased mobility For post-surgical repair: Inclusion Criteria: adults, flap repair where the donor or recipient site is on the posterior side of the patient, or trauma patients with a surgical procedure on the posterior side of the patient, ability to provide consent or have a legal representative to provide consent on their behalf, partially or entirely dependent on mobility for the first 14-21 days post-surgery, ALOS is over 14 days Exclusion Criteria: a patient has complications that result in near end of life with death imminent, the patient becomes more mobile (e.g., can sit up from supine without assistance or can roll to the side without assistance) in less than 14 days
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Barry W Baylis, MD
    Phone
    (403)220-2859
    Email
    baylis@ucalgary.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wrechelle Ocampo, MBT
    Phone
    (403)210-7792
    Email
    wbocampo@ucalgary.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barry W Baylis, MD
    Organizational Affiliation
    University of Calgary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Implementation and Evaluation of CBPM Technology

    We'll reach out to this number within 24 hrs