Preclinical Evaluation, Clinical Trial Preparation and a Prospective Clinical

在美国，每年进行的胃肠道切除和吻合术超过30万例。 独自一人。5%-15%的患者术后吻合口裂开或渗漏 并与严重的术后发病率和死亡率有关。前期临床前 研究表明，充分的组织氧合在吻合口的重要性。 预防术后渗漏和并发症。外科医生传统上评估组织的存活能力 仅通过简单的肉眼检查即可获得血液供应。一种评价吻合口组织活力的方法 术中手术将有助于实施矫正措施和改善手术结果。我们 假设无线脉搏血氧饱和度(WiPOX)实时监测组织氧合 该装置提供了可靠的、客观的组织灌注量，并能检测到组织缺血。 比目视检查更早，从而允许采取纠正措施以减少术后发病率 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-此手持设备和微型探头提供 为外科医生提供实时、准确和方便的组织氧合监测。这不会 只有使外科医生能够实时监测血管受损，以便纠正任何管道 扭转，但也将允许外科医生自信地选择最大的氧合部位 吻合。该提案将包括以下三个关键设备开发和验证步骤 临床应用(AIMS)：1)使用已经在试点临床试验中验证的WiPOX模型，我们将 对接受食道胃切除术的患者进行前瞻性临床试验，测试 WiPOX可以(A)预测由于组织氧合(Ti02)损害而导致的吻合口漏，以及 (2)优化Ti02吻合口围手术期，减少术后吻合口漏。2)至 开发和测试一种新的WiPOX模型来检测接受手术患者的早期皮瓣缺血 微血管游离组织移植用于乳房再造并进行试点临床试验。3) 开发一种基于嵌入网格的多传感器阵列来包裹肝脏或心脏的新平台 并在大型动物身上测试该设备，以实时检测手术中的血流损害 在肝脏切除和心脏搭桥手术期间。

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.