Real-Time VLS Detection of Colon Ischemia in AAA Repair

AAA 修复中结肠缺血的实时 VLS 检测

• 批准号: 7477102
• 负责人: David A. Benaron
• 金额: $ 54.53万
• 依托单位: SPECTROS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7477102
• 关键词: Abdomen; Abdominal Aortic Aneurysm; Acute; Address; Adult; Anesthesia procedures; Aneurysm; Aortic Aneurysm; Blood Vessels; California; Catheters; Cause of Death; Cessation of life; Clinical; Colon; Complication; Death Rate; Detection; Devices; Early Diagnosis; Enrollment; Financial cost; Genus Cola; Goals; Grant; Hospitals; Hour; Human; Infarction; Injury; Intervention; Ischemia; Lead; Left; Life; Measures; Mesentery; Monitor; Multicenter Trials; Numbers; Operative Surgical Procedures; Outcome; Outcome Measure; Patients; Perfusion; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Population; Prevention; Principal Investigator; Rate; Research; Risk; Rupture; Ruptured Abdominal Aortic Aneurysm; Safety; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Sterility; System; Techniques; Testing; Time; United States Food and Drug Administration; United States National Institutes of Health; Visible Radiation; biomaterial compatibility; clinical application; clinical efficacy; cost; day; design; experience; improved; pilot trial; prevent; programs; prospective; rectal; repaired; success

DESCRIPTION (provided by applicant): We saved patient lives in Phase I, and met or exceed all Phase I milestones. We now propose to verify and extend these results in an expanded trial at 3 leading clinical centers (Stanford, Univ. of California, VA). This Phase II SBIR proposal addresses the need to detect colon ischemia associated with the repair of Abdominal Aortic Aneurysm (AAA), a lethal complication of AAA repair. An abdominal aneurysm is found in 5% of adults over 50, and its repair or rupture is the 13th leading cause of death in the U.S. A lethal complication of AAA repair is colon ischemia (1-2% rate of ischemia to the gut, confirmed in 2004 studies from NYU, SUNY, and DREAM study). Of those developing moderate to severe colon ischemia after AAA repair, the majority die before leaving the hospital of irreversible colon infarction. Early surgical intervention improves outcome ONLY if the ischemia is detected and treated within hours. Once the colon dies and the patientnitoring. In Phase I, we developed and tested a rectal probe to detect acute ischemia, and changed outcome. PHASE I RESULTS: PATIENTS w/ PROBE PATIENTS w/o PROBE Number of Patients in Phase I Study 38 Study Patients 526 Controls ICU Days (patients w/ischemia) 2 Days in ICU 29 Days in ICU (p<0.001) Death Rate (patients w/ischemia) 0% Died 55% Died The specific aims of this Phase II (R44) proposal are: (1) to manufacture a commercializable probe to FDA standards, (2) to extend the R43 study into a pivotal NIH-Phase Ill-Type multi-center trial of 500 patients undergoing AAA repair, validating the clinical efficacy of colon monitoring on 5 outcome measures. If successful, the probe will be commercialized. Spectros founders have already founded and taken other biotech firms public (Xenogen), and Spectros itself is selling an SBIR-supported product for anesthesia use.

描述（由申请人提供）：我们在第一阶段挽救了患者的生命，并达到或超过了第一阶段的所有里程碑。我们现在建议在 3 个领先的临床中心（斯坦福大学、加利福尼亚大学、弗吉尼亚州）进行扩大试验来验证和扩展这些结果。该 II 期 SBIR 提案解决了检测与腹主动脉瘤 (AAA) 修复相关的结肠缺血的需求，腹主动脉瘤 (AAA) 是 AAA 修复的致命并发症。 5% 的 50 岁以上成年人患有腹部动脉瘤，其修复或破裂是美国第 13 大死亡原因。AAA 修复的致命并发症是结肠缺血（已证实，肠道缺血率为 1-2%） 2004 年纽约大学、纽约州立大学和 DREAM 研究的研究）。在 AAA 修复后出现中度至重度结肠缺血的患者中，大多数在出院前因不可逆的结肠梗塞而死亡。只有在数小时内发现并治疗缺血时，早期手术干预才能改善预后。一旦结肠死亡，患者就需要进行监测。在第一阶段，我们开发并测试了直肠探针来检测急性缺血，并改变了结果。 第一阶段结果：带探针的患者 不带探针的患者 I 期研究患者人数 38 名研究患者 526 名对照者 ICU 天数（缺血患者） 在 ICU 中的 2 天 在 ICU 中的 29 天 (p<0.001) 死亡率（缺血患者） 0% 死亡 55% 死亡 该 II 期 (R44) 提案的具体目标是：(1) 制造符合 FDA 标准的可商业化探针，(2) 将 R43 研究扩展到关键的 NIH III 期多中心试验，该试验有 500 名患者参与AAA 修复，验证结肠监测对 5 项结果指标的临床疗效。如果成功，该探测器将被商业化。 Spectros 创始人已经创立了其他生物技术公司 (Xenogen) 并将其上市，而 Spectros 本身正在销售 SBIR 支持的麻醉用产品。

项目成果

The management of large bilateral internal iliac artery aneurysms using the T-Stat Colon Oximeter.

使用 T-Stat 结肠血氧计治疗大型双侧髂内动脉瘤。

• 发表时间: 2010-01
• 影响因子: 1.5
• 作者: Lee, Eugene S;Dawson, David L
• 通讯作者: Dawson, David L

Use of T-Stat to predict colonic ischemia during and after endovascular aneurysm repair: a case report.

使用 T-Stat 预测血管内动脉瘤修复期间和之后的结肠缺血：病例报告。

• 发表时间: 2008-03
• 影响因子: 4.3
• 作者: Lee, Eugene S;Pevec, William C;Link, Daniel P;Dawson, David L
• 通讯作者: Dawson, David L