Development of a novel method for cannulation in pediatric cardiac procedures

开发小儿心脏手术中插管的新方法

• 批准号: 10286952
• 负责人: Can Yerebakan
• 金额: $ 23.83万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-06 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10286952
• 关键词: 3D Print; Adoption; Animal Testing; Animals; Aorta; Back; Blood; Blood Vessels; Brain; Bypass; Caliber; Cannulas; Cannulations; Cardiac; Cardiac Surgery procedures; Cardiopulmonary; Cardiopulmonary Resuscitation; Cardiovascular system; Chest; Childhood; Clinical; Clinical Research; Consumption; Development; Devices; Diagnosis; Effectiveness; Environment; Extracorporeal Membrane Oxygenation; Failure; Family suidae; Future; Goals; Hand; Heart; Hemorrhage; In Situ; Incidence; Infection; Institutes; Intercept; Mechanics; Methods; Modeling; Morbidity - disease rate; National Institute of Child Health and Human Development; Neck; Neurologic; Neurologic Deficit; Operative Surgical Procedures; Outcome; Oxygen; Oxygenators; Patients; Population; Procedures; Prognosis; Pump; Research Project Grants; Respiratory Failure; Right atrial structure; Route; Rupture; Savings; Secure; Source; Structure; Surgical incisions; Surgical sutures; System; Techniques; Testing; Time; Tissues; Tourniquets; Venous; Weaning; Work; base; body system; design; experience; heart dimension/size; improved outcome; innovation; mortality; novel; pediatric patients; pressure; prevent; programs; prototype; standard of care; tool

Project Summary The goal of this proposal is to develop a quick-connect cannulation system to allow rapid, easy, and safe cannulation in pediatric cardiac patients. Extracorporeal membrane oxygenation (ECMO) has emerged as a vital tool for saving patients suffering cardiovascular and/or respiratory failure. However, even in well experienced hands, the initiation of ECMO support is relatively time consuming in a stressful environment with frequent complications. The goal of this R21 proposal submission is to develop a novel quick-connection cannulation system to allow for rapid, easy, and safe cannulation in the pediatric population. This proposal is being submitted to PA- 18-482 after discussion with NICHD program officers. We will accomplish this through two specific aims. Aim 1: Develop new rapid cannulation device. A new rapid cannulation device will be developed and prototyped. The device will be designed to securely attach to current commercial arterial and venous cannulas from 8Fr-16Fr in diameter and tested for mechanical stability on a tensile testing machine. Aim 2: Evaluate device in bench top and swine animal tests. The device will first be evaluated in a bench test using 3D printed model hearts and a closed loop pressurized system to mimic cardiac flow. Once these tests are successful, swine animal trials will be done using expired pigs from other research projects at our institute. The successful completion of this project will provide us with a prototype device that can move towards clinical studies in future work, which would include developing a biodegradable version. An alternative safe, easy, and fast cannulation procedure may reduce the duration of E-CPR by minimizing the time needed for secure cannulation, reducing or even preventing potential damage to the brain and other organ systems. Such an innovation has the potential to significantly improve outcomes both in terms of mortality and morbidity of pediatric patients undergoing E-CPR.

项目概要 该提案的目标是开发一种快速连接插管系统，以实现快速、简单和安全 小儿心脏病患者的插管。体外膜肺氧合（ECMO）已成为一种 拯救心血管和/或呼吸衰竭患者的重要工具。然而，即使在良好 对于经验丰富的人员来说，在压力较大的环境下启动 ECMO 支持相对耗时 频繁出现并发症。 本 R21 提案提交的目标是开发一种新颖的快速连接插管系统 允许对儿科人群进行快速、简单且安全的插管。该提案正在提交给 PA- 18-482 与 NICHD 项目官员讨论后。我们将通过两个具体目标来实现这一目标。 目标1：开发新型快速插管装置。将开发一种新的快速插管装置 原型。该设备将设计为牢固地连接到当前的商业动脉和静脉插管 直径为 8Fr-16Fr，并在拉伸试验机上测试机械稳定性。 目标 2：在台式和猪动物测试中评估设备。该设备将首先在工作台上进行评估 使用 3D 打印心脏模型和闭环加压系统来模拟心血流进行测试。一旦这些 测试成功，猪动物试验将使用我们其他研究项目的过期猪进行 研究所。 这个项目的成功完成将为我们提供一个原型设备，可以迈向 未来工作中的临床研究，其中包括开发可生物降解的版本。替代安全， 简单、快速的插管程序可以通过最大限度地减少 E-CPR 所需的时间来缩短 E-CPR 的持续时间 安全插管，减少甚至防止对大脑和其他器官系统的潜在损害。这样的 一项创新有可能显着改善死亡率和发病率方面的结果 接受 E-CPR 的儿科患者。