Cortical Health Index Monitor (CHI)

皮质健康指数监测仪 (CHI)

• 批准号: 7108888
• 负责人: Neil S. Rothman
• 金额: $ 99.32万
• 依托单位: INFINITE BIOMEDICAL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7108888
• 关键词: biomedical equipment development; brain electrical activity; brain injury; cerebral ischemia /hypoxia; clinical research; clinical trials; diagnosis design /evaluation; early diagnosis; electroencephalography; health services research tag; heart arrest; human subject; patient monitoring device; patient oriented research

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.

描述（由申请人提供）：仅在美国，心脏骤停每年就夺去超过45万人的生命。幸存者中神经系统并发症的发生率很高，这些并发症是发病的主要原因。在过去的几年里，通过引入新的全身性和神经特异性治疗，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，在关键的最初几小时到几天的逮捕后，评估神经系统的状态，在这些患者基本上是不存在的。因此，需要一种客观有效的工具来评估预后和跟踪早期恢复期的神经系统状态。为了满足这一需求，我们开发了皮质健康指数（CHI）。该基于EEG的指数结合了与皮质恢复相关的多个加权参数。这种方法的强度和独特性的结果从考虑的时间以及频谱域。我们的II期研究结果表明，在30例心脏骤停患者的研究中，在心脏骤停后前6小时内测量的CHI与出院时的临床结局密切相关。我们现在建议寻求CHI Monitor的监管批准。我们的计划包括一项前瞻性临床试验，涉及4个中心和100例患者。我们将测试CHI 1）预测心脏骤停患者后续神经功能结局的能力，以及2）提供脑损伤和治疗反应的实时跟踪。该项目的成功完成由CHI监测器的FDA批准定义。我们的目标是CHI监测器将识别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专家提供这些信息代表了心脏骤停幸存者护理服务的重大变化。