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 摘要 肥胖症是一种慢性、复发性、多因素和神经行为疾病，需要终生治疗， 多学科管理超越单一干预。目前的治疗方案， 病态肥胖包括药物治疗，其仅引起次优的体重减轻，和减肥手术， 只有一小部分符合条件的患者使用。内镜袖状胃成形术（ESG）是快速 作为对抗肥胖流行病的一种新工具出现， 以及（ii）对于手术后体重增加的患者进行内窥镜翻修。它是一种安全有效， 使用柔性内窥镜进行无切口、非手术技术，通过口腔引入， 其通过从胃腔内放置全层缝合线来减小胃体积。这是一天的 门诊手术，快速恢复工作。然而，学习执行ESG在技术上是 要求很高，至少需要35个案例才能达到基本熟练程度。通过内窥镜 内窥镜检查技能对于ESG至关重要，仅学习内窥镜检查不足以执行ESG。 在以患者为中心的环境、社会和管治之外， 医学和程序教育的学徒模式，预计将基于虚拟现实（VR） 具有视觉和触觉反馈的培训师将对ESG培训非常宝贵，使学员能够获得 在受控环境中的能力，对患者没有风险;能够定制学习，并提供 实时反馈、指导和客观评估。本提案的目标是设计， 开发并验证虚拟减肥内窥镜（ViBE）模拟器，可用于培训 内窥镜减肥手术，如ESG。本项目的重大技术创新包括：（1） 开发ESG程序的现实物理实时模拟，包括一个有效的 约束样条动力学（CSD）算法用于内窥镜手术建模，（2）创新硬件 在ESG过程中用于精确力反馈的接口，（3）体内猪实验，以表征 内窥镜手术;和（4）认知辅助模块，基于详细的认知任务 分析，向受训者提供实时反馈。我们将对自愿报名的学生进行实验， 参与者确保在ViBE上学习适当的技能，并在 ViBE反映了适当的技术技能。此外，我们将测试假设， ViBE模拟器将以与在离体猪上训练的模拟器相同或更好的速率学习 胃肠标本，这种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，并提出开发一种 模拟器，以确保ESG的安全采用。在ViBE上学习的内窥镜检查技能将转化为 其它的内窥镜手术，例如，支架固定和减肥手术并发症的管理。