Pressure InjuryCBPMNCT05363475
Implementation and Evaluation of CBPM Technology
A study testing ForeSite Intelligent Surface in people with Pressure Injury and Surgical Wound, run by Barry Baylis.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Surgical Wound
- What is being tested?
- ForeSite Intelligent Surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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:
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implementation and Evaluation of a Continuous Bedside Pressure Mapping System in Multiple Patient Care Settings
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:
Read more
- 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.
- Conditions
- Pressure Injury, Surgical Wound
- Being tested
- ForeSite Intelligent Surface
- Medical subject headings
- Pressure Ulcer, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForeSite Intelligent SurfaceDevice
Also called ForeSite IS
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Experimental | Participants will be monitored by the ForeSite Intelligent Surface system for 2-3 weeks. Receives: Device: ForeSite Intelligent Surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-3 weeks during monitoring
Providing evidence of skin breakdown
Incidence of pressure injuries and skin assessments correlated to average interface pressure, average pressure exposure and peak pressure
Measured: 2 weeks during monitoring
Improves healing of surgical wounds
Skin and surgical site infections correlated to average interface pressure, average pressure exposure and peak pressure
Measured: 2-3 weeks during monitoring
Secondary outcomes (2)
Improving nursing workflow
rate of repositioning per day, average exposure time between repositions and duration of body positions
Measured: 2-3 weeks
Cost-effectiveness
cost of care per quality adjusted life year
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort with comparison to retrospective cohort
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barry Baylis
- Sponsor type
- University, hospital or other
- Collaborators
- XSENSOR Technology Corporation
- Responsible party
- Sponsor-investigator, Barry Baylis, University of Calgary
- Investigators
- Barry W Baylis, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363475
- Sponsor's protocol ID
- REB22-0239
- Acronym
- CBPM
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Continuous Bedside Pressure Mapping System in Multiple Patient Care Settings
- ClinicalTrials.gov ID
- NCT05363475
- Acronym / sponsor ID
- CBPM / REB22-0239
- Conditions
- Pressure Injury, Surgical Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Barry BaylisUniversity, hospital or other
- Collaborators
- XSENSOR Technology Corporation
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort with comparison to retrospective cohort
| Arm | Type | Receives |
|---|---|---|
| Prospective | Experimental | Device: ForeSite Intelligent SurfaceParticipants will be monitored by the ForeSite Intelligent Surface system for 2-3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- 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
Key exclusion criteria (3 listed)
- near end of life, have a planned admission to another unit, their clinical care would be negatively impacted if turned or repositioned, increased mobility
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForeSite Intelligent SurfaceAlso: ForeSite ISThe 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. | Device | Prospective |
Primary outcome
Incorporating the ForeSite IS in nursing care
Time frame: 2-3 weeks during monitoring
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
Time frame: 2 weeks during monitoring
Incidence of pressure injuries and skin assessments correlated to average interface pressure, average pressure exposure and peak pressure
Improves healing of surgical wounds
Time frame: 2-3 weeks during monitoring
Skin and surgical site infections correlated to average interface pressure, average pressure exposure and peak pressure
2 secondary outcomes
Improving nursing workflow
Time frame: 2-3 weeks
Cost-effectiveness
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry W Baylis, MD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing ForeSite Intelligent Surface in people with Pressure Injury and Surgical Wound, run by Barry Baylis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barry W Baylis, MD ((403)220-2859, baylis@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incorporating the ForeSite IS in nursing care (time frame: 2-3 weeks during monitoring). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.