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

项目摘要 大约75万美国人，大约全球有450万患者患有终末期肾病(ESRD)1- 3.人口老龄化以及与ESRD相关的合并症的增加是预期的 ESRD4患者增加。导致这种高发病率和死亡率的主要原因之一是 与维持正常的血管通路相关的并发症5-7。一个重要的和潜在的 可避免的并发症是在插管时动静脉瘘(AVF)的损伤 对于正在进行血液透析的患者，每周在透析诊所进行三次。在插管过程中，针可以 以这样的方式插入，使得瘘管或移植物血管壁被穿孔，从而潜在地导致了一种“渗透”11 导致患者不能透析，甚至失去血管通路。因此，当前的状态 插管被称为ESKD血管通路的“阿喀琉斯脚跟”。由于行业营业额很高， 缺乏熟练程度评估工具，最重要的是，缺乏有效的培训工具、专门知识和 不同的插管工人熟练程度各不相同。存在许多培训工具，例如“低技术含量” Mannikins(例如“假手臂”)、兼容超声的模型(例如蓝色幻影血管通道)和“High-Phantom 技术“模拟器。现有工具的问题包括：1)目前没有可用的有效培训人员， 特殊的血液透析插管，2)当前模拟器缺乏真实感，降低了它们的教育价值， 3)缺乏技能评估和培训的指标。旅居医疗技术公司正在开发CanSim 模拟器，一种智能的、个性化的、特定于透析的培训器，用于学习至关重要的插管技能 透析护士和病人护理技术员(PCT)。对这种硬件和软件集成的需求 发生的大量常规插管损伤(以及由此产生的并发症)导致了装置的出现 每天在全国各地的诊所。CanSim不仅将显著改善患者的预后，它还将 使透析工作人员更有信心，并对患者体验产生积极影响。CanSim 技术是基于对原始原型(S)进行了七年多的广泛研究 设备15-17，数据来自&gt；80新手和经验丰富的插管器。各种研究的结果都得出了 在使用模拟模型量化插管技能的验证指标中18-21，并激励设计和 商业CanSim设备的测试--这是STTR第1阶段提案的目标。初级阶段 CanSim的特点如下：1.专用于透析，2.逼真且低维护的设计，以及 3.基于指标的个性化反馈。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的关键组件(以及相关固件)，以集成到第一个 Can Sim商业产品和2)我们将创建并测试一个评估用户质量的模型 通过客观指标在模拟器上进行插管尝试。结果将为全面评估提供基础 CamSim商业产品的第二阶段。

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.