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: 10488261
• 负责人: Xin Kang
• 金额: $ 71万
• 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 2024-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10488261
• 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; 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; ultrasound

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.

项目摘要/摘要 末期肾脏疾病（ESRD）影响全球430万例患者，占所有患者的7％ 医疗保险和医疗补助费用。最普遍的肾脏替代方式，血液透析， 需要访问连接透析机械的循环。首选 进入方法是动静脉（AV）瘘管，因为它赋予死亡率较低，感染率 但是，干预措施是透析技术人员插管的最具挑战性的。 插管损伤是AV瘘并发症和故障的主要原因之一。 6个月内，91％的患者发生了插管失败和伤害。这些伤害可能导致 严重的并发症，例如血肿，感染和动脉瘤形成，包括死亡 出血，对发病率，住院，访问修订和损失有次要影响 访问。重大渗透的年度速率为5.2％，每次事件都导致额外的97 导管依赖的天数和2.4诊断测试，手术任命的平均值或 干预措施。当考虑额外的导管时间和次要干预时， 财务影响为每次重大渗透$ 21,441。 超声已经证明，通过减少CVC时间来大大改善预后 > 30％（50天），感染37％。但是，这是在肾脏病医生的手中 在研究环境和当前的超声选项中，对于透析技术人员和 因此不使用。 我们已经开发了一种自动3D超声导航解决方案Echoguide，即 透析技术人员的目的是在没有专门培训的情况下改善插管。这 研究建议证明，当透析技术人员使用时，回声可以实质上 减少AV瘘管的插管误差和渗透。 在此II阶段提案中，我们将（1）使用自定义探针/显示开发集成的回声 硬件，管腔检测算法和实时交互式导航； （2）迭代用户 通过人为因素开发接口以优化导航指南； （3）扩展 经过验证的AVF插管模拟器启用超声兼容性以证明 在挑战方面，技术人员在改善技术人员的成功方面有效性 AVF场景。 总体影响：Echoguide将允许快速成功地插入AV瘘管。这会 降低与重大渗透和相关导管相关的发病率和成本 时间和其他干预措施。