Intraoperative Brain Dysfunction Monitor/Detector

术中脑功能障碍监测仪/探测器

• 批准号: 7294914
• 负责人: TATJANA ZIKOV
• 金额: $ 26.64万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-02-06 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7294914
• 关键词: Affect; Algorithms; Anesthesia procedures; Arts; Blood flow; Brain; Brain Injuries; Brain Ischemia; Cardiovascular Surgical Procedures; Cessation of life; Clinical; Communities; Coronary Artery Bypass; Data; Depth; Drops; Early Diagnosis; Electroencephalography; Ensure; Environment; Face; Functional disorder; Impaired cognition; Interruption; Ischemia; Location; Medical Device; Medical center; Monitor; Motor; Neurological outcome; Operating Rooms; Operative Surgical Procedures; Patients; Pattern; Postoperative Period; Procedures; Scalp structure; Seizures; Signal Transduction; Speech; System; Technology; Time; Vision; base; cardiovascular risk factor; data acquisition; detector; indexing; novel; programs; research clinical testing

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).

描述（由申请人提供）：在此程序中，我们建议开发一个高级术中监测器神经元，以早日检测到脑功能障碍和缺血。 该监测器在心血管手术期间将特别有用，因为这些过程特别容易诱发术后和术后脑损伤。 外科团队面临的主要困难之一是血液流向大脑的潜在中断，例如以下主动脉或颈动脉夹紧。 这可能导致大脑缺血，这是大脑中氧合水平的临界下降，这严重影响了神经系统结局（认知障碍，癫痫发作，运动/语音/言语/视力功能的丧失以及最终死亡）。 我们提出的术中脑功能障碍监测器/检测器将通过对从多个头皮位置获得的脑电图的实时分析来量化和分析手术患者的皮质活性。 拟议的系统将利用Cleveland Medical Devices Inc.（Clevemed）开发的最先进技术，用于在电气敌对环境（例如手术室（OR））中的神经生理数据采集。 这种术中神经监测硬件将与增强的基于小波的基于小波的算法-AV的增强的MUTLI渠道版本集成，该算法是由PI开发的，用于基于单个额叶EEG通道的麻醉监测的定量深度。 该程序中要开发的多通道皮质活动指数（M-WAV）将代表对全球大脑状态的实时评估。 此外，M-WAV索引将被编译为警告算法模块，该模块将根据指示局部/全局脑功能障碍的皮质活动预定模式发出警报。为了确保临床社区认可神经元，拟议的系统将在两种高风险心血管手术过程中使用来自两个医疗中心的数据进行广泛的临床评估 - 冠状动脉旁路移植物（CABG）和Carotide肠结肠术和切除术（CEA）。