SBIR-STTR Award

About 750,000 Americans and approx. 4.5 million patients worldwide have End-Stage Renal Disease (ESRD)1– 3. Aging population as well as rise in ESRD-related comorbidities are key factors in the anticipated rate of increase in patients with ESRD4. One of the primary causes for this high morbidity and mortality are the complications associated with maintaining a functioning vascular access5–7. An important and potentially avoidable complication is injury to the arteriovenous fistula (AVF) at the time of cannulation, which is performed in the dialysis clinics three times per week for patients on hemodialysis8. During cannulation needles can be inserted in such a way that the fistula or graft vessel wall is perforated causing an “infiltration”11, potentially resulting in a patient not being able to dialyze or even losing the vascular access. As such, the current state of cannulation has been dubbed the “Achilles Heel” of vascular access in ESKD. Due to high industry turnover, lack of proficiency assessment tools, and, most importantly, a lack of effective training tools, expertise and proficiency varies among workers performing cannulation. Many training tools exist, such as “low-tech mannikins (e.g. “fake arms”), ultrasound-compatible models (e.g. Blue Phantom Vascular Access), and “high- tech” simulators. The problems with available tools include: 1) no currently available effective trainers that are specific hemodialysis cannulation, 2) lack of realism in current simulators diminishes their educational value, and 3) absence of metrics for skill assessment and training. Sojourn MedTech is developing the CanSim simulator, a smart, personalized, and dialysis-specific trainer for learning cannulation skills that are critical for dialysis nurses and patient care technicians (PCTs). The need for this hardware and software integrated device arises from the large number of routine cannulation injuries (and resultant complications) that occur daily in clinics across the country. CanSim will not only substantially improve patient outcomes, it will also enable a more confident dialysis workforce as well as positively impact patient experience. CanSim technology is based on more than seven years of extensive research on the original prototype(s) of the device15–17, with data from >80 novice and experienced cannulators. Results for various studies have resulted in validated metrics for quantifying cannulation skill18–21 using simulation models and motivate the design and testing of the commercial CanSim devices— the objective of this STTR Phase 1 proposal. The primary features of the CanSim are as follows: 1. Dialysis-specific, 2. Realistic and low-maintenance design, and 3. Metrics-based personalized feedback. During Phase I, we will complete the following aims: 1) We will engineer and refine key components of our hardware (and associated firmware) to be integrated into the first CanSim commercial products and 2) We will create and test a model for assessing quality of a user’s cannulation attempts on the simulator via objective metrics. Results will provide the basis for a full assessment of the CamSim commercial product in Phase II.

Public Health Relevance Statement:
Project Narrative An important and potentially avoidable complication for the 4.5 million patients worldwide with End-Stage Renal Disease is injury to the arteriovenous fistula at the time of cannulation, which is performed in the dialysis clinics three times per week for patients on hemodialysis. Due to high industry turnover, lack of proficiency assessment tools, and, most importantly, a lack of effective training tools, expertise and proficiency varies among workers performing cannulation. Sojourn MedTech is developing the CanSim simulator, a smart, personalized, and dialysis-specific trainer for learning cannulation skills that are critical for dialysis nurses and patient care technicians.

Project Terms:
Anatomic Sites; Anatomic structures; Anatomy; Anxiety; Arteriovenous fistula; AV fistula; Arteriovenous Aneurysm; Blood Vessels; vascular; comorbidity; co-morbid; co-morbidity; Complication; Credentialing; Dialysis procedure; Dialysis; dialysis therapy; Education; Educational aspects; Engineering; Feedback; Fistula; Patient Care; Patient Care Delivery; Hemodialysis; Hemodialyses; Hemorrhage; Bleeding; blood loss; Industry; Learning; Maintenance; Minor; Morbidity - disease rate; Morbidity; mortality; Needles; Care given by nurses; Nursing Care; Client satisfaction; Patient Satisfaction; Patients; Research; Risk; Computer software; Software; South Carolina; Standardization; Technology; Testing; Time; Psychological Transfer; learning transfer; training transfer; Measures; Catheters; medical costs; Medical Care Costs; Caring; Guidelines; injuries; Injury; sensor; improved; Procedures; Clinical; Phase; Link; Training; Exposure to; Infiltration; tool; Mechanics; mechanic; mechanical; Complex; Dependence; Clinic; Source; Techniques; Country; Perforation; skills training; American; experience; Structure; skills; models and simulation; model-based simulation; Devices; Human Resources; Manpower; personnel; Excision; Abscission; Extirpation; Removal; Surgical Removal; resection; Modeling; Cannulations; ESRD; End-Stage Kidney Disease; End-Stage Renal Disease; End stage renal failure; Data; Detection; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Small Business Technology Transfer Research; STTR; Process; neglect; designing; design; Outcome; clinical relevance; clinically relevant; usability; prototype; aged population; population aging; aging population; arm; Assessment instrument; Assessment tool; pilot test; ultrasound