Development and Validation of a Virtual Bariatric Endoscopic (ViBE) Simulator

虚拟减肥内窥镜 (ViBE) 模拟器的开发和验证

• 批准号: 10007968
• 负责人: Suvranu De
• 金额: $ 69.42万
• 依托单位: RENSSELAER POLYTECHNIC INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-19 至 2021-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10007968
• 关键词: 3-Dimensional; Adopted; Algorithms; American; Anatomy; Animals; Auditory; Bariatrics; Body Weight decreased; Body mass index; Cadaver; Certification; Clinical; Cognitive; Comorbidity; Competence; Complex; Computer Simulation; Computers; Controlled Environment; Cues; Custom; Defect; Development; Devices; Diabetes Mellitus; Diagnostic; Diet; Education; Educational Curriculum; Endoscopes; Endoscopy; Enrollment; Ensure; Environment; Esophageal; Esthesia; Excision; FDA approved; Family suidae; Feedback; Fistula; Gastrectomy; Gastric Bypass; Gastroenterologist; Gastrointestinal Endoscopy; Gastroplasty; Goals; Gold; Health Services Accessibility; Healthcare; Hypertension; Hypertriglyceridemia; Intelligence; Interdisciplinary Study; Intervention; Learning; Life Style; Manufacturer Name; Measures; Medical; Mentors; Modeling; Morbidity - disease rate; Mucous Membrane; Obesity; Operative Surgical Procedures; Oral; Participant; Patient-Focused Outcomes; Patients; Perforation; Performance; Physics; Procedures; Professional Organizations; Regimen; Reproducibility; Research; Research Project Grants; Risk; Specimen; Standardization; Stents; Stomach; Surgeon; Surgical sutures; System; Task Performances; Technical Expertise; Techniques; Technology; Thick; Time; Tissues; Touch sensation; Training; Translating; Treatment Cost; Validation; Visual; apprenticeship; bariatric surgery; base; clinical practice; cognitive task; cost; design; diet and exercise; experimental study; flexibility; frontier; gastrointestinal; haptics; high risk; high risk population; improved; in vivo; innovation; instrument; minimally invasive; multidisciplinary; novel; patient population; procedure safety; sample fixation; simulation; skills; task analysis; tool; virtual; virtual reality

Development and Validation of a Virtual Bariatric Endoscopic (ViBE) Simulator Abstract Endoscopic Sleeve Gastroplasty (ESG) is rapidly emerging as a viable non-surgical option to millions of patients with Class 3 Obesity (Body Mass Index [BMI] ≥ 40 kg/m2) or Class 2 Obesity (BMI 35 to <40) with comorbidities who have failed multiple attempts at diet and lifestyle changes but are unable to undergo bariatric surgery due to its cost, risk and access to care. ESG is a trans-oral flexible endoscopy technique which significantly reduces the volume of the stomach by suturing it from within the gastric lumen. Studies have shown that it is a safe and reproducible procedure that is associated with significant durable weight loss and reduction of co-morbidities associated with obesity. However, learning to perform ESG is technically demanding with a minimum of 35 cases necessary to attain basic proficiency. This is because ESG requires complex maneuvers using a specialized FDA-approved endoscopic suturing system to apply full-thickness sutures. With no formal curriculum or competency standards in place for ESG outside the patient-centric apprenticeship model of medical and procedural education, it is anticipated that a virtual reality (VR)-based trainer, with visual and haptic (touch) feedback, will be invaluable for training in ESG, allowing trainees to attain competence in a controlled environment with no risk to patients; to enable customized learning; and to offer real time feedback, mentoring and objective assessment. The goal of the present proposal is to design, develop and validate a Virtual Bariatric Endoscopic (ViBE) simulator that can be used to train endoscopic bariatric procedures such as ESG. A multidisciplinary team has been assembled to achieve the following Specific Aims: (SA 1) Develop the visual and haptic environment for the ViBE: Specifically, we will develop (1) highly realistic 3D anatomical and tool models involved in ESG, and (2) haptic hardware interface for the clinician to interact seamlessly with the virtual patient anatomy. (SA 2) Develop the physical simulation environment for the ViBE: Specifically, we will (1) develop realistic physics-based real-time simulations of the ESG procedure including a novel constrained spline dynamics (CSD) algorithm for modeling of endoscopic suturing, (2) perform in vivo endoscopic suturing studies to provide design specifications for the haptic interface and to validate the computational models, (3) develop metrics of task performance and goal scores which will serve as end points of learning and (4) develop an intelligent cognitive assistant that will provide real-time feedback identifying errors as well as visual and auditory cues to guide the trainee. (SA 3) Establish the validity and usefulness of the ViBE as a training tool: We will conduct experiments on voluntarily enrolled participants to ensure that appropriate skills are being learned on the ViBE and performance measured on the ViBE reflects the appropriate technical skills. Further, we will study if training on the ViBE is superior to training on ex vivo porcine specimens, and transfers positively to the clinical setting.

虚拟减肥内窥镜(VIBE)模拟器的开发与验证 摘要 内窥镜袖状胃成形术(ESG)正迅速成为数百万患者的可行非手术选择 3级肥胖(体重指数≥40公斤/平方米)或2级肥胖(体重指数35至40)的患者 多次尝试改变饮食和生活方式失败，但无法接受 减肥手术由于其成本、风险和获得护理的机会。ESG是一种经口腔的柔性内窥镜技术 它通过从胃腔内缝合来显著减少胃的体积。研究 已经证明，这是一种安全和可重复的手术，与显著的持久减肥有关 以及减少与肥胖相关的并发症。然而，从技术上讲，学习执行ESG 要求至少35个案例才能达到基本熟练程度。这是因为ESG需要 使用FDA批准的专门的内窥镜缝合系统进行复杂的操作，以应用全厚度 缝合线。 除了以患者为中心之外，ESG没有正式的课程或能力标准 医学和程序性教育的学徒制模式，预计将是一种基于虚拟现实(VR)的 Trader具有视觉和触觉(触摸)反馈，对于ESG培训将是无价的，使受训人员能够获得 在受控环境中的能力，不会对患者造成风险；支持定制学习；并提供 实时反馈、指导和客观评估。本提案的目标是设计， 开发和验证可用于培训的虚拟减肥内窥镜(VIBE)模拟器 内窥镜减肥手术，如ESG。已经组建了一个多学科团队来实现 以下具体目标：(SA 1)为氛围开发视觉和触觉环境：具体地说，我们 将开发(1)ESG中涉及的高真实感3D解剖和工具模型，以及(2)触觉硬件 用于临床医生与虚拟患者解剖结构无缝交互的界面。(SA 2)发展身体素质 Vibe的模拟环境：具体地说，我们将(1)开发基于真实物理的实时 包括一种新的约束样条动力学(CSD)算法的ESG过程的模拟 内窥镜缝合的建模，(2)进行体内内窥镜缝合研究，以提供设计 触觉接口规范和验证计算模型，(3)开发任务度量 成绩和目标分数，将作为学习的终点和(4)开发智能 认知助手，将提供识别错误的实时反馈以及视觉和听觉提示 指导实习生。(SA 3)确定氛围作为一种培训工具的有效性和有用性：我们将 对自愿登记的参与者进行实验，以确保学习到适当的技能 在Vibe上测量的氛围和表现反映了适当的技术技能。此外，我们还将 研究氛围训练是否优于体外猪标本训练，并正向传递给 临床环境。