Preclinical Evaluation, Clinical Trial Preparation and a Prospective Clinical

临床前评估、临床试验准备和前瞻性临床

• 批准号: 8744974
• 负责人: KAREN HUBBARD
• 金额: $ 15.77万
• 依托单位: CITY COLLEGE OF NEW YORK
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-26 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8744974
• 关键词: Anastomosis - action; Animals; Blood Vessels; Blood flow; Cardiopulmonary Bypass; Clinical; Clinical Trials; Community Outreach; Device or Instrument Development; Devices; Education and Outreach; Engineering; Excision; Extravasation; Hand; Heart; Investigation; Ischemia; Liver; Mammaplasty; Measures; Memorial Sloan-Kettering Cancer Center; Methods; Modeling; Monitor; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Patients; Perfusion; Postoperative Period; Preparation; Pulse Oximetry; Research Training; Site; Surgeon; Surgical Flaps; Testing; Time; Tissue Viability; Tissues; Validation; Vascular blood supply; Visual; Wireless Technology; anticancer research; base; clinical application; gastrointestinal; improved; innovation; mortality; pre-clinical; preclinical evaluation; prevent; prospective; sensor; tissue oxygenation

More than 300,000 gastrointestinal resection and anastomosis per year are performed in the U.S. alone. Dehiscence or leakage from anastomotic sites following surgery occurs in 5-15% of patients and is associated with significant post-operative morbidity and mortality. Prior preclinical investigations have shown the importance of adequate tissue oxygenation at the anastomosis in preventing post-operative leakage and complications. Surgeons traditionally assess tissue viability and blood supply by simple visual inspection only. A method to assess anastomotic tissue viability intraoperatively would help perform corrective measures and improve surgical outcomes. We hypothesize that real-time monitoring of tissue oxygenation by wireless pulse oximetry (WiPOX) device provides a reliable, objective measure of tissue perfusion, and can detect tissue ischemia earlier than visual inspection, thereby allowing corrective actions to reduce post-operative morbidity and mortality. Our engineering (CCNY) and surgical (MSKCC) teams collaborated to develop and validate an innovative WiPOX device - this hand-held device and miniature probe provides operating surgeons with real-time, accurate, and convenient monitoring of the tissue oxygenation. This will not only enable the surgeon to monitor vascular compromise in real time in order to rectify any conduit twisting, but will also allow the surgeon to confidently select the site of maximal oxygenation for the anastomosis. This proposal will include pivotal device development and validation steps in three clinical applications (Aims): 1) Using a WiPOX model already validated in pilot clinical trials, we will conduct a prospective clinical trial of patients undergoing esophagogastrectomy, testing whether WiPOX can (a) predict anastomotic leaks resulting from tissue oxygenation (Ti02) compromise, and (b) optimize peri-anastomotic Ti02, thereby decrease post-operative anastomotic leakage. 2) To develop and test a new WiPOX model to detect early flap ischemia in patients undergoing microvascular free tissue transfer for breast reconstruction and conduct a pilot clinical trial. 3) Develop a new platform based on a multi-sensor array embedded in mesh to envelope a liver or heart and test the device in large animals for detecting real-time intraoperative blood flow compromise during liver resections and heart bypass surgery.

美国每年进行超过 300,000 例胃肠切除和吻合手术 独自的。 5-15% 的患者术后会出现吻合口裂开或渗漏 并与显着的术后发病率和死亡率相关。先前的临床前 研究表明，吻合时充分组织氧合的重要性 防止术后渗漏和并发症。外科医生传统上评估组织活力 和血液供应仅通过简单的目视检查。评估吻合组织活力的方法 术中将有助于采取纠正措施并改善手术结果。我们 假设通过无线脉搏血氧仪 (WiPOX) 实时监测组织氧合 装置提供可靠、客观的组织灌注测量，并可以检测组织缺血 早于目视检查，从而可以采取纠正措施来减少术后发病率 和死亡率。我们的工程 (CCNY) 和外科 (MSKCC) 团队合作开发和 验证创新的 WiPOX 设备 - 该手持设备和微型探头提供操作 外科医生可以实时、准确、便捷地监测组织氧合情况。这不会 仅使外科医生能够实时监测血管受损情况，以便纠正任何导管 扭转，但也可以让外科医生自信地选择最大氧合作用的部位 吻合术。该提案将包括三个方面的关键设备开发和验证步骤 临床应用（目标）： 1) 使用已在试点临床试验中验证的 WiPOX 模型，我们将 对接受食管胃切除术的患者进行前瞻性临床试验，测试是否 WiPOX 可以 (a) 预测因组织氧合 (Ti02) 受损而导致的吻合口渗漏，以及 (b)优化吻合口周围的TiO 2 ，​​从而减少术后吻合口漏。 2) 至 开发并测试一种新的 WiPOX 模型来检测接受手术的患者的早期皮瓣缺血 微血管游离组织移植用于乳房重建并进行试点临床试验。 3） 开发一个基于嵌入网格的多传感器阵列的新平台，以包裹肝脏或心脏 并在大型动物身上测试该装置，以检测实时术中血流受损情况 在肝脏切除术和心脏搭桥手术期间。