Intraoperative Brain Dysfunction Monitor/Detector
Department of Health and Human Services
Agency Tracking Number:
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Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, 44103
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (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).
* information listed above is at the time of submission.