A Smart Simulator for Metrics-based Cannulation Skills Training for Hemodialysis

用于基于指标的血液透析插管技能培训的智能模拟器

• 批准号: 10830667
• 负责人: Lydia Petersen
• 金额: $ 31.21万
• 依托单位: SOJOURN MEDTECH LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10830667
• 关键词: American; Anatomy; Anxiety; Arteriovenous fistula; Assessment tool; Blood Vessels; Cannulations; Care given by nurses; Caring; Catheters; Client satisfaction; Clinic; Clinical; Complex; Complication; Computer software; Country; Credentialing; Data; Dependence; Detection; Devices; Dialysis procedure; Education; End stage renal failure; Engineering; Excision; Exposure to; Feedback; Fistula; Guidelines; Hemodialysis; Hemorrhage; Human Resources; Industry; Infiltration; Injury; Learning; Link; Maintenance; Measures; Mechanics; Medical Care Costs; Minor; Modeling; Morbidity - disease rate; Needles; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Perforation; Phase; Procedures; Process; Psychological Transfer; Research; Risk; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Source; South Carolina; Standardization; Structure; Techniques; Technology; Testing; Time; Training; aging population; arm; clinically relevant; comorbidity; design; experience; improved; models and simulation; mortality; neglect; pilot test; prototype; sensor; skills; skills training; tool; ultrasound; usability

Project Summary 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.

项目摘要 约75万美国人和大约。4.5全球有100万患者患有终末期肾病（ESRD）1- 3.人口老龄化以及ESRD相关合并症的增加是预期死亡率的关键因素。 ESRD患者增加4。发病率和死亡率高的主要原因之一是 与维持血管通路功能相关的并发症5 -7。一个重要的和潜在的 可避免的并发症是插管时动静脉瘘（AVF）损伤， 在透析诊所为接受血液透析的病人每周提供三次8。在插管期间，针可以 以瘘管或移植血管壁穿孔的方式插入， 导致患者不能透析或甚至失去血管通路。因此，目前的 插管被称为ESKD血管通路的“阿喀琉斯之踵”。由于行业周转率高， 缺乏熟练程度评估工具，最重要的是，缺乏有效的培训工具、专业知识和 进行插管的工人熟练程度各不相同。存在许多培训工具，例如“低技术 人体模型（例如“假臂”）、超声兼容模型（例如蓝色体模血管通路）和“高- 技术”模拟器。现有工具的问题包括：1）目前没有有效的培训人员， 特定的血液透析插管，2）当前模拟器缺乏真实性降低了其教育价值， 缺乏技能评估和培训的指标。Sojourn MedTech正在开发CanSim 模拟器，一种智能、个性化和透析专用培训器，用于学习插管技能， 透析护士和患者护理技术人员（PCT）。需要这种硬件和软件的集成 该器械是由于发生大量常规插管损伤（以及由此产生的并发症） 每天在全国各地的诊所进行。CanSim不仅将大大改善患者的治疗效果， 使透析工作人员更加自信，并对患者体验产生积极影响。CanSim 技术是基于对原始原型的七年多的广泛研究， 器械15 -17，数据来自>80名新手和经验丰富的插管者。各种研究的结果已经导致 在使用模拟模型量化插管技能18 -21的经验证指标中， 商用CanSim设备的测试-本STTR第1阶段提案的目标。主 CanSim的特点如下：1.透析专用，2.实用和低维护设计，以及 3.基于度量的个性化反馈。在第一阶段，我们将完成以下目标：1）我们将 设计和改进我们硬件（及相关固件）的关键组件，以集成到第一个中 CanSim商业产品和2）我们将创建和测试一个模型，用于评估用户的 通过客观指标在模拟器上尝试插管。结果将为全面评估提供依据 第二阶段的CamSim商业产品。