Validation of a Bedside Automated 3D Ultrasound-based Arteriovenous Fistula Cannulation Guidance Solution to Improve AV Fistula Outcomes

验证基于 3D 超声的床边自动动静脉内瘘插管引导解决方案，以改善 AV 瘘的结果

• 批准号: 10384715
• 负责人: Xin Kang
• 金额: $ 100万
• 依托单位: SONAVEX, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2023-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384715
• 关键词: 3D ultrasound; Adoption; Algorithms; Aneurysm; Appointment; Area; Arteriovenous fistula; Blood; Blood Circulation; Caliber; Cannulations; Catheters; Central Venous Access Catheter; Cessation of life; Clinical; Complex; Custom; Dependence; Detection; Development; Diagnostic; Diagnostic tests; Dialysis Solutions; Dialysis patients; Dialysis procedure; Effectiveness; End stage renal failure; Failure; Feedback; Fistula; Health Expenditures; Hematoma; Hemodialysis; Hemorrhage; Hospitalization; Human; Infection; Infiltration; Injury; Intervention; Kidney; Kidney Failure; Lead; Location; Medicare/Medicaid; Methods; Modality; Morbidity - disease rate; Navigation System; Needles; Nephrology; Operative Surgical Procedures; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Phase; Physicians; Procedures; Risk; Sepsis; System; Testing; Thrombosis; Time; Training; Trauma; Ultrasonography; Validation; Venous; Visit; Visual; Work; arteriovenous graft; automated algorithm; base; blood filtration; cost; experience; image guided; improved; improved outcome; intervention cost; mortality; prevent; skills; success

PROJECT SUMMARY/ABSTRACT End Stage Renal Disease (ESRD) impacts 4.3M patients worldwide and accounts for 7% of all Medicare and Medicaid costs. The most prevalent modality of renal replacement, hemodialysis, requires access to the circulation through which dialysis machinery is connected. The preferred method of access is an arteriovenous (AV) fistula as it confers lower rates of mortality, infection and interventions, however they are the most challenging for dialysis technicians to cannulate. Cannulation damage is one of the primary causes of AV fistula complications and failure. Cannulation failures and injury occur in 91% of patients within 6 months. These injuries can lead to serious complications, such as hematoma, infection, and aneurysm formation including death from hemorrhage, with a secondary impact on morbidity, hospitalization, access revision, and loss of access. The annual rate of major infiltration is 5.2%, with each incident leading to an extra 97 days of catheter dependency and a mean of 2.4 diagnostic tests, surgery appointments, or interventions. When factoring in the additional catheter time and secondary interventions, the financial impact is $21,441 per major infiltration. Ultrasound has been demonstrated to dramatically improve outcomes by reducing CVC time by >30% (50 days) and infections by 37%. However, this was in the hands of nephrology physicians in a study setting and current ultrasound options are too challenging for dialysis technicians and are therefore not used. We have developed an automated 3D ultrasound-based navigation solution, EchoGuide, that is purpose build for dialysis technicians to improve cannulation without specialized training. This study proposes to prove that EchoGuide, when used by dialysis technicians, can substantially reduce cannulation errors and infiltrations for AV fistulae. In this Phase II proposal, we will (1) develop the integrated EchoGuide with custom probe/display hardware, lumen detection algorithms, and real-time interactive navigation; (2) iterate user interface via human factors development to optimize navigation guidance; and (3) extend a validated AVF cannulation simulator to enable ultrasound compatibility in order to demonstrate EchoGuide effectiveness in improving cannulation success by technicians across challenging AVF scenarios. OVERALL IMPACT: EchoGuide will allow rapid and successful cannulation of AV fistulae. This will reduce both the morbidity and costs associated with major infiltration and the associated catheter time and additional interventions.

项目概要/摘要 终末期肾病 (ESRD) 影响着全球 430 万患者，占全部患者的 7% 医疗保险和医疗补助费用。最普遍的肾脏替代方式是血液透析 需要进入连接透析机的循环系统。首选 进入方法是动静脉（AV）瘘，因为它具有较低的死亡率和感染率 和干预措施，但对于透析技术人员来说，它们是最具挑战性的插管。 插管损伤是动静脉瘘并发症和失败的主要原因之一。 91% 的患者在 6 个月内发生插管失败和受伤。这些伤害可能会导致 严重并发症，如血肿、感染和动脉瘤形成，包括死亡 出血，对发病率、住院治疗、通路翻修和损失产生次要影响 的访问权限。年重大渗透率为 5.2%，每次事件导致额外 97 导管依赖天数以及平均 2.4 次诊断测试、手术预约或 干预措施。当考虑到额外的导管时间和二次干预时， 每次重大渗透的财务影响为 21,441 美元。 超声已被证明可以通过缩短 CVC 时间来显着改善结果 >30%（50 天），感染率增加 37%。然而，这掌握在肾脏内科医生手中 在研究环境中，当前的超声选项对于透析技术人员来说太具有挑战性，并且 因此不被使用。 我们开发了一种基于 3D 超声的自动化导航解决方案 EchoGuide，即 专为透析技术人员打造，无需专门培训即可改进插管。这 研究旨在证明 EchoGuide 在被透析技术人员使用时可以显着 减少插管错误和 AV 瘘管浸润。 在此第二阶段提案中，我们将 (1) 开发带有定制探头/显示器的集成 EchoGuide 硬件、流明检测算法、实时交互导航； (2)迭代用户 通过人为因素开发界面来优化导航引导； (3) 延长 经过验证的 AVF 插管模拟器可实现超声兼容性，以便演示 EchoGuide 在提高技术人员应对挑战的插管成功率方面的有效性 AVF 场景。 总体影响：EchoGuide 将允许快速、成功地对 AV 瘘管进行插管。这将 降低与主要浸润和相关导管相关的发病率和费用 时间和额外的干预措施。