Putting EEG in the Emergency Department

描述(申请人提供)：在美国医院急诊科每年1.19亿名患者中，有2%-10%的患者精神状态(AMS)改变，但脑电(EEG)目前不在用于诊断这些患者病情的快速一线测试之列。这是一个明显的未得到满足的需求，当我们考虑到EEG是对大脑电活动的非侵入性记录，这对于诊断非抽搐状态癫痫是必不可少的，这一点变得更加明显。癫痫状态是威胁生命的，而且经常出现在患有AMS的急诊室的患者中。事实上，在大多数医院，ED患者根本无法获得EEG。教育署不使用脑电图仪的常见理由包括仪器稀少和费用昂贵、轮候时间长，以及缺乏购置和操作这些专用仪器所需的空间、时间、资金和专业知识。克服这些和其他障碍将有助于使EEG成为急诊室的标准，研究表明，这可以改善患者护理，并可能还降低医疗成本。 首先，我们建议完成一个廉价系统的开发，以便在急诊室快速记录高质量的脑电，并从可能不在现场的神经科医生那里获得解释。我们会为教育署优化现有的数码无线“微脑电波”装置。目前的微型脑电最初是为大规模伤亡事件中的癫痫检测而开发的，并在电噪声的ED环境中可靠地记录高质量、无伪影的脑电。我们将把微型脑电与一次性/翻新电极组件结合起来，创造出一种使用方便的脑电图盒。我们将添加病例管理软件来处理脑电记录，以便将它们发送到非现场神经科医生进行解释，因为大多数急诊室没有获得读取脑电记录的许可的神经科医生。其次，我们将在一项针对AMS患者的随机对照试验中，评估使用EEG系统如何影响AMS人群的患者结局和护理成本。最后，我们将获得FDA 510(K)的批准，将该系统推向急救药物市场。 公共卫生相关性：在医院急诊科，多达10%的患者的精神状态(AMS)发生了变化。虽然他们的大脑活动可以直接通过脑电(EEG)进行评估，并为医生提供宝贵的信息，以便快速准确地诊断他们的病情，但大多数急诊科无法获得EEG和解释这些信息所需的专家。我们建议优化一种微型、廉价的脑电记录套件，并创建用于脑电管理的软件，以便向急诊科医生提供位于其他地方的脑电专家的快速脑电解释。

DESCRIPTION (provided by applicant): Of the 119 million patients in U.S. hospital emergency departments annually, 2-10% present with altered mental status (AMS), but the electroencephalogram (EEG) is currently not among the set of rapid, first-line tests that are used to diagnose the conditions of these patients. This is a glaring unmet need, made all the more apparent when we consider that the EEG is a non-invasive recording of electrical brain activity that is indispensable for diagnosing non-convulsive status epilepticus, which is lifethreatening and frequent among patients visiting the ED with AMS. In fact, in most hospitals, EEG is not available to ED patients at all. Commonly cited reasons for not using EEG in the ED include the scarcity and expense of equipment, long waiting times, as well as the lack of space, time, funds, and expertise needed to acquire and operate this dedicated equipment. Overcoming these and other obstacles will help make EEG a standard in the ED, which studies show can improve patient care and probably also reduce health care costs. We propose, first, to complete development of an inexpensive system to rapidly record high-quality EEG in the ED and obtain an interpretation from a neurologist that may be off-site. We will optimize our existing digital wireless 'microEEG' device for the ED. The current microEEG was originally developed for seizure detection during mass casualty events, and reliably records high-quality, artifact-free EEG in the electrically-noisy ED environment. We will combine microEEG with disposable/refurbishable electrode components to create a convenient to use EEG-kit. We will add case management software to process the EEG recordings so they may be sent to off-site neurologists for interpretation because most EDs do not have a neurologist licensed to read EEGs. Second, we will evaluate how using the EEG system impacts patient outcomes and cost of care in the AMS population in a randomized control trial on AMS patients. Finally, we will obtain FDA 510(k) approval to market the system for emergency medicine. PUBLIC HEALTH RELEVANCE: As many as 10% of patients in hospital emergency departments have altered mental status (AMS). While the activity of their brains can be directly assessed by the electroencephalogram (EEG) and provide the physician with valuable information for making a rapid and accurate diagnosis of their condition, EEG and the specialists needed to interpret them are not available in most emergency departments. We propose to optimize a miniature, inexpensive EEG recording kit and create software for EEG management to provide a rapid EEG interpretation to the emergency department physician from EEG specialists that can be located elsewhere.