Intraoperative Brain Dysfunction Monitor/Detector

描述(由申请人提供)： 在这个项目中，我们建议开发一种先进的术中无线监测器，用于早期检测脑功能障碍和脑缺血，特别适合心血管手术。心血管手术是特别容易在手术中和术后造成脑损伤的手术。手术团队面临的主要困难之一是，例如，在主动脉或颈动脉夹闭后，流向大脑的血液最终会中断。这可能会导致脑-脑缺血中氧气水平的严重下降，从而严重影响神经预后(认知障碍、癫痫发作、运动/言语/视觉功能丧失，最终导致死亡)。我们建议的术中脑功能障碍/检测器将通过实时分析手术过程中从多个头皮位置获得的脑电来量化和分析患者的皮质活动。该系统将克利夫兰医疗设备公司最先进的微型无线生物遥测技术与PI最近开发的一种新的、非常有前途的基于小波的算法的增强多通道版本相结合，用于基于单个额部EEG通道的麻醉深度定量监测。该项目将开发的多通道皮质活动指数将呈现全球大脑状态的实时状态。此外，这些指数将被警告算法模块使用，该模块将基于指示局部大脑功能障碍的几种预定的皮质活动模式进行警报。在第一阶段接近尾声时，拟议的系统将在两个医疗中心的手术室进行广泛的临床评估。

DESCRIPTION (provided by applicant): In this program, we propose to develop an advanced intraoperative wireless monitor for the early detection of brain dysfunction and ischemia that would be particularly suited for cardiovascular surgeries. Cardiovascular surgeries are procedures particularly prone to intra- and postoperative brain injury. One of the major difficulties faced by the surgical team is the eventual interruption of blood flow to the brain following, for example, aortic or carotid clamping. This can result in a critical drop in the oxygenation level in the brain - brain ischemia which seriously affects the neurologic outcome (cognitive impairment, seizures, loss of motor/speech/vision functions, and ultimately, death). Our proposed intraoperative brain dysfunction/detector will quantify and analyze cortical activity of the patient by real-time analysis of EEG acquired from multiple scalp locations during the surgical procedure. The proposed system combines state-of-the art miniature wireless bio-telemetry technology of the Cleveland Medical Devices Inc. with an enhanced multi-channel version of a novel and very promising wavelet-based algorithm recently developed by the PI for quantitative monitoring of anesthetic depth based on a single frontal EEG channel. The multi-channel cortical activity indexes to be developed in this program will present a real-time status of the global brain state. In addition, these indexes will be employed by a warning algorithm module, which will enable an alarm based on several predetermined patterns of cortical activity indicative of local brain dysfunction. Toward the end of Phase I, the proposed system will undergo an extensive clinical evaluation at the operating rooms of two medical centers.