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: 10709569
• 负责人: Suvranu De
• 金额: $ 51.04万
• 依托单位: FLORIDA AGRICULTURAL AND MECHANICAL UNIV
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10709569
• 关键词: 3-Dimensional; Adoption; Algorithms; American; Anatomy; Animals; Auditory; Bariatrics; Body Weight decreased; Body mass index; Cadaver; Certification; Chronic; Clinical; Cognitive; Competence; Complex; Computer Models; Computers; Controlled Environment; Cues; Data; Decision Making; Defect; Development; Devices; Diagnostic; Disease; Education; Educational Curriculum; Eligibility Determination; Endoscopes; Endoscopy; Environment; Esthesia; Excision; FDA approved; Family suidae; Feedback; Fistula; Gastric Bypass; Gastroenterologist; Gastroplasty; Goals; Healthcare; Interdisciplinary Study; Intervention; Knowledge; Learning; Learning Skill; Manufacturer; Measures; Medical; Mentors; Modeling; Morbid Obesity; Mucous Membrane; Obesity; Obesity Epidemic; Operative Surgical Procedures; Oral; Oral cavity; Organ; Outpatients; Patient-Focused Outcomes; Patients; Perforation; Performance; Pharmacotherapy; Physics; Procedures; Process; Professional Organizations; Recovery; Recurrent disease; Regimen; Relapse; Research; Research Project Grants; Risk; Risk Reduction; Safety; Specific qualifier value; Specimen; Standardization; Stents; Stomach; Surgeon; Surgical complication; Surgical sutures; System; Task Performances; Technical Expertise; Techniques; Technology; Testing; Thick; Time; Tissues; Touch sensation; Training; Translating; Treatment Cost; Validation; Visual; Weight Gain; Work; apprenticeship; bariatric surgery; cognitive task; combat; comorbidity; cost; design; esophageal stents; experience; experimental study; flexibility; force feedback; gastrointestinal; haptic interface; haptics; high risk; improved; in vivo; innovation; instrument; lifestyle intervention; multidisciplinary; neurobehavioral; participant enrollment; sample fixation; simulation; simulation environment; skills; task analysis; tool; treatment strategy; virtual; virtual environment; virtual patient; virtual reality

Development and Validation of a Virtual Bariatric Endoscopic (ViBE) Simulator Abstract Obesity is a chronic, relapsing, multifactorial, and neurobehavioral disease that requires life-long, multidisciplinary management beyond a single intervention. The current treatment options for patients with morbid obesity include pharmacotherapy, which only induces suboptimal weight loss, and bariatric surgery, utilized only by a small fraction of the eligible patients. Endoscopic Sleeve Gastroplasty (ESG) is rapidly emerging as a new tool to combat the obesity epidemic used both as (i) primary weight loss procedure and (ii) endoscopic revision for patients experiencing weight gain following surgery. It is a safe and effective, incision-less, non-surgical technique performed with a flexible endoscope, introduced through the mouth, which reduces the gastric volume by placing full-thickness sutures from within the gastric lumen. It is a one-day outpatient procedure with rapid return to work. However, learning to perform ESG is technically demanding, with a minimum of 35 cases necessary to attain basic proficiency. Though endoscopic suturing skills are critical for ESG, just learning endoscopic suturing is not sufficient for performing ESG. 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. Significant technical innovations of this project include (1) developing realistic physics-based real-time simulations of the ESG procedure, including an efficient constrained spline dynamics (CSD) algorithm for modeling endoscopic suturing, (2) an innovative hardware interface for accurate force feedback during ESG, (3) in vivo porcine experiments to characterize the endoscopic suturing procedure; and (4) a cognitive assistant module, based on detailed cognitive task analysis, to provide real-time feedback to the trainee. 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 test the hypothesis that trainees who train on the ViBE simulator will learn at the same rate or better than those trained on ex vivo porcine gastrointestinal specimens and that this training will transfer to the clinical environment. The significance of this project is that it focuses on the obesity epidemic and proposes to develop a simulator to enable the safe adoption of ESG. Endoscopic suturing skills learned on the ViBE will translate to other endoscopic procedures, e.g., stent fixation and management of bariatric surgical complications.

虚拟减肥内窥镜 (ViBE) 模拟器的开发和验证 抽象的 肥胖是一种慢性、复发性、多因素的神经行为疾病，需要终生、 超越单一干预的多学科管理。目前患者的治疗选择 病态肥胖包括仅导致体重减轻不理想的药物治疗和减肥手术， 仅一小部分符合条件的患者使用。内窥镜袖状胃成形术（ESG）正在迅速 正在成为对抗肥胖流行的新工具，同时用作（i）主要减肥程序 (ii) 针对手术后体重增加的患者进行内窥镜修正。它是一种安全、有效、 使用柔性内窥镜通过口腔引入的无切口、非手术技术， 通过从胃腔内放置全层缝合线来减少胃体积。这是一个一日游 门诊手术可快速恢复工作。然而，学习执行 ESG 在技术上是很困难的 要求很高，至少需要35个案例才能达到基本熟练程度。虽然内窥镜 缝合技术对于 ESG 至关重要，仅学习内镜缝合不足以进行 ESG。 在以患者为中心之外，没有正式的 ESG 课程或能力标准 医学和程序教育的学徒模式，预计基于虚拟现实（VR）的 具有视觉和触觉（触摸）反馈的培训师对于 ESG 培训非常宝贵，可以让学员获得 在受控环境中的能力，对患者没有风险；实现定制学习，并提供 实时反馈、指导和客观评估。本提案的目标是设计， 开发并验证可用于训练的虚拟减肥内窥镜 (ViBE) 模拟器 内窥镜减肥手术，例如 ESG。本项目的重大技术创新包括（1） 开发基于物理的 ESG 程序实时模拟，包括高效的 用于建模内窥镜缝合的约束样条动力学 (CSD) 算法，(2) 创新硬件 ESG 期间精确力反馈的接口，(3) 体内猪实验来表征 内窥镜缝合程序； (4)基于详细认知任务的认知辅助模块 分析，为学员提供实时反馈。我们将对自愿加入的人进行实验 参与者确保在 ViBE 上学习适当的技能并在 ViBE 上衡量绩效 ViBE 反映了适当的技术技能。此外，我们将检验以下假设：接受培训的学员 ViBE 模拟器的学习速度与在离体猪上训练的模拟器相同或更好 胃肠道标本，并且该培训将转移到临床环境。 该项目的意义在于它关注肥胖流行病并提出开发一种 模拟器，以实现 ESG 的安全采用。在 ViBE 上学到的内窥镜缝合技能将转化为 其他内窥镜手术，例如支架固定和减肥手术并发症的处理。