Cortical Health Index (CHI) Monitor - Regulatory Approval

皮质健康指数 (CHI) 监测仪 - 监管机构批准

• 批准号: 7221245
• 负责人: Neil S. Rothman
• 金额: $ 100.29万
• 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/7221245
• 关键词: Affect; American; Brain; Brain Injuries; Caring; Cerebrum; Clinical; Clinical Research; Clinical Trials; Counseling; Critical Care; Data; Electroencephalography; Environment; Evaluation; Family member; Foundations; Goals; Health; Heart Arrest; Hospitals; Hour; Human; Incidence; Individual; Injury; Institution; International; Intervention; Life; Love; Measures; Medical; Methods; Mind; Monitor; Morbidity - disease rate; Motivation; Neurologic; Neurological outcome; Neurological status; Outcome; Patient Care; Patients; Phase; Recovery; Research Personnel; Resuscitation; Series; Severities; Signal Transduction; Speed; Survivors; System; Systemic Therapy; Testing; Time; United States; United States Food and Drug Administration; Validation; Weight; Wireless Technology; Work; base; care delivery; day; design; disability; functional outcomes; improved; indexing; innovation; outcome forecast; prospective; response; tool

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，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，这是导致发病率的主要原因。在过去的几年里，通过引入新的全身和神经特异性治疗方法，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个小时到几天内，对这些患者的神经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跟踪早期恢复期的神经状态。针对这一需要，我们开发了皮质健康指数(CHI)。这个基于EEG的指数包含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源于对时间域和谱域的考虑。我们的第二阶段结果表明，在一项30例心脏骤停患者的研究中，在心跳骤停后的前6小时内测量的CHI与出院时的临床结果密切相关。我们现在建议寻求监管部门对CHI Monitor的批准。我们的计划包括一项涉及4个中心和100名患者的前瞻性临床试验。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)提供对脑损伤和治疗反应的实时跟踪。该项目的成功完成取决于FDA对CHI监视器的批准。我们的目标是CHI监测将确定哪些患者可以从积极的干预中受益，然后跟踪治疗的反应。在复苏后立即向治疗心脏病专家提供这一信息代表着对心脏骤停幸存者的护理服务发生了重大变化。