Intraoperative Brain Dysfunction Monitor/Detector

描述（由申请人提供）：在本项目中，我们计划开发一种先进的术中监测仪NeuroGUARD，用于早期检测脑功能障碍和缺血。 该监视器在心血管手术期间特别有用，因为这些手术特别容易引起术中和术后脑损伤。 手术团队面临的主要困难之一是血液流向大脑的潜在中断，例如，主动脉或颈动脉夹闭。 这可能导致脑缺血，即脑中氧合水平的严重下降，严重影响神经功能结局（认知障碍、癫痫发作、运动/言语/视觉功能丧失，最终导致死亡）。 我们提出的术中脑功能障碍监测器/检测器将通过实时分析从多个头皮位置获取的EEG来量化和分析手术患者的皮质活动。 申报系统将采用Cleveland Medical Devices Inc.开发的最先进技术。（CleveMED），用于在诸如手术室（OR）等电气恶劣环境中进行神经生理数据采集。 该术中神经监测硬件将与一种基于小波的新型算法- WAV的增强型多通道版本集成，该算法由PI开发，用于基于单个额叶EEG通道的定量麻醉深度监测。 在该计划中开发的多通道皮层活动指数（M-WAVs）将代表对全球大脑状态的实时评估。 此外，M-WAV指数将被编译成一个警告算法模块，该模块将根据指示局部/全局脑功能障碍的皮质活动的预定模式发出警报。为了确保临床社区认可NeuroGUARD，将使用两个医疗中心在两种高风险心血管手术-冠状动脉旁路移植术（CABG）和Carotide Entarterectomy（CEA）期间的数据对申报系统进行广泛的临床评价。

DESCRIPTION (provided by applicant): In this program, we propose to develop an advanced intra-operative monitor, the NeuroGUARD, for the early detection of brain dysfunction and ischemia. This monitor will be particularly useful during cardiovascular surgeries since these procedures are specially prone to inducing intra- and post-operative brain injury. One of the major difficulties that surgical team faces is the potential interruption of blood flow to the brain for example, the following aortic or carotid clamping. This can result in brain ischemia, a critical drop in the oxygenation level in the brain, which seriously affects the neurologic outcome (cognitive impairment, seizures, loss of motor/speech/vision functions, and ultimately, death). Our proposed intra-operative brain dysfunction monitor/detector will quantify and analyze cortical activity of the surgical patient through real-time analysis of EEG acquired from multiple scalp locations. The proposed system will utilize state-of-the-art technology developed by Cleveland Medical Devices Inc. (CleveMED), for neurophysiologic data acquisition in electrically hostile environments such as the Operating Room (OR). This intra-operative neuromonitoring hardware will be integrated with an enhanced mutli-channel version of a novel wavelet-based algorithm - WAV, which was developed by the PI for quantitative depth of anesthesia monitoring based on a single frontal EEG channel. The multi-channel cortical activity indexes (M-WAVs) to be developed in this program will represent a real-time assessment of the global brain state. In addition, the M-WAV indexes will be compiled into a warning algorithm module, which will signal an alarm based on predetermined patterns of cortical activity indicative of local/global brain dysfunction. In order to ensure that the clinical community endorses the NeuroGUARD, the proposed system will undergo an extensive clinical evaluation using data from two medical centers during two high-risk cardiovascular procedures - Coronary Artery Bypass Graft (CABG) and Carotide Entarterectomy (CEA).