Implementation and Evaluation of CBPM Technology

Surgical Wound Clinical Trial

— CBPM  

Official title:

Implementation and Evaluation of a Continuous Bedside Pressure Mapping System in Multiple Patient Care Settings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05363475
• Other study ID #: REB22-0239
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2022
• Source: University of Calgary
• Contact: Barry W Baylis, MD
• Phone: (403)220-2859
• Email: baylis[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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:

1. 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

2. To determine if the ForeSite IS system can provide evidence of skin breakdown to reduce the incidence and risk of PIs

3. To determine if the ForeSite IS system can assist with offloading of pressure to improve healing of post-surgical patients

The secondary objectives are:

1. To determine if the device improves nursing workflow and productivity

2. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 31, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Surgical Wound

Intervention

Device:
• ForeSite Intelligent Surface
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Barry Baylis	XSENSOR Technology Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2-3 weeks during monitoring
Primary	Providing evidence of skin breakdown	Incidence of pressure injuries and skin assessments correlated to average interface pressure, average pressure exposure and peak pressure	2 weeks during monitoring
Primary	Improves healing of surgical wounds	Skin and surgical site infections correlated to average interface pressure, average pressure exposure and peak pressure	2-3 weeks during monitoring
Secondary	Improving nursing workflow	rate of repositioning per day, average exposure time between repositions and duration of body positions	2-3 weeks
Secondary	Cost-effectiveness	cost of care per quality adjusted life year	6 months