Cortical Health Index Monitor (CHI)

描述（由申请人提供）：仅在美国，每年就有超过45万人死于心脏骤停。幸存者中神经系统并发症的发生率很高，这是发病的主要原因。在过去的几年中，通过引入新的系统和神经特异性疗法，这些患者的护理得到了改善。治疗机构的速度似乎是影响疗效的重要因素。然而，在逮捕后关键的最初几小时到几天内，对这些患者的神经系统状态的评估基本上是不存在的。因此，需要一种客观有效的工具来评估预后，并在早期恢复期跟踪神经系统状态。针对这一需求，我们开发了皮质健康指数（CHI）。这个基于脑电图的指数包含了与皮质恢复相关的多个加权参数。该方法的强度和独特性源于同时考虑了时间域和谱域。我们的II期研究结果表明，在一项30例心脏骤停患者的研究中，在骤停后最初6小时内测量的CHI与出院时的临床结果密切相关。我们现在建议监管部门批准CHI监测器。我们的计划包括一项前瞻性临床试验，涉及4个中心和100名患者。我们将测试CHI的能力，1)预测心脏骤停患者随后的神经功能结果，2)实时跟踪脑损伤和对治疗的反应。该项目的成功完成取决于FDA对CHI监测器的批准。我们的目标是，CHI监测器将识别出可以从积极干预中受益的患者，然后跟踪对治疗的反应。在复苏后立即向治疗心脏病的专家提供这一信息代表了对心脏骤停幸存者护理的重大改变。

DESCRIPTION (provided by applicant): Cardiac arrest claims over 450,000 lives per year in the United States alone. There is a high incidence of neurological complications amongst survivors, and these represent the leading cause of morbidity. Over the past several years, the care of these patients has been improved via the introduction of new systemic as well as neurospecific therapies. Speed of institution of therapy appears to be an important factor affecting efficacy. Yet, in the crucial initial hours to days post-arrest, assessment of neurological status in these patients is essentially non-existent. Thus, there is a need for an objective validated tool to assess prognosis and to track neurological status in the early recovery period. In response to this need, we have developed the Cortical Health Index (CHI). This EEG-based index incorporates multiple weighted parameters which are related to cortical recovery. The strength and uniqueness of this approach results from consideration of both the temporal as well as the spectral domains. Our Phase II results demonstrate that CHI measured within the first 6-hours post-arrest is strongly correlated with clinical outcome at hospital discharge in a 30-patient cardiac arrest study. We now propose to pursue regulatory approval of the CHI Monitor. Our plan involves a prospective clinical trial involving 4 centers and 100 patients. We will test the ability of CHI to 1) predict subsequent neurological functional outcome of cardiac arrest patients, and 2) provide real-time tracking of brain injury and response to therapy. Successful completion of this project is defined by FDA clearance of the CHI Monitor. It is our goal that the CHI Monitor will identify patients who could benefit from aggressive intervention, and then track the response to the therapy. Providing this information to the treating cardiologist in the immediate post-resuscitation period represents a major change in care delivery for the cardiac arrest survivor.