PRE-HOSPITAL TREATMENT OF STATUS EPILEPTICUS

癫痫持续状态的院前治疗

• 批准号: 3418342
• 负责人: DANIEL H LOWENSTEIN
• 金额: $ 42.74万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-08-18 至 1998-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3418342
• 关键词: brain disorder chemotherapy; clinical trials; diazepam; electroencephalography; emergency care; epilepsy; human subject; human therapy evaluation; lorazepam

Status epilepticus (SE) occurs in 45,000 to 65,000 persons annually in the United States and is a medical emergency that requires prompt, effective intervention. Despite the development of effective anticonvulsant therapies, and the recognition that prolonged SE is associated with poor neurological outcome, there is often a significant delay between the onset of SE and successful termination of seizures with conventional treatment. This is due both to the time required for transport of patients to an emergency care facility and, in a significant number of patients, a lack of response to initial anticonvulsant treatment. In 1990, the San Francisco Emergency Medical Services (EMS) system developed a protocol that allowed paramedics to administer intravenous diazepam for the treatment of SE in the field. A preliminary analysis of this protocol suggests that patients who received pre-hospital diazepam therapy had fewer seizures in the emergency department, SE of shorter duration, and were intubated less often than patients in whom conventional anticonvulsant therapy was initiated after hospital arrival. These data indicate that pre-hospital treatment of SE may simplify subsequent management and have a beneficial impact on the clinical course and outcome of patients. Nonetheless, the potential benefits and complications of this treatment strategy have not been assessed in a rigorous manner. This is of particular concern because the respiratory complications of intravenous diazepam may be severe, and reports from EMS systems elsewhere in the U.S. suggest that pre-hospital benzodiazepine therapy of SE is gaining popularity despite the lack of a well designed clinical trial to assess its value. This grant proposal describes a multicenter, prospective, randomized, double-blind study designed to compare the safety and efficacy of intravenous diazepam or lorazepam versus placebo when administered in the field by paramedics to adult patients in SE. The study takes advantage of the highly-centralized San Francisco EMS system which is based at San Francisco General Hospital (SFGH). Paramedics will verify the diagnosis of SEE, administer study drugs, and assess patients during transport while having continual radio contact with an attending physician and Medical Intensive Care Nurse at SFGH. The assessment of patients will include observations of clinical seizure activity, level of consciousness, vital signs, cardiac rhythms, and oxygenation via pulse oximetry. Paramedics will also hook-up an ambulatory EEG recording unit to each study patient at the time of initial contact, and continuous recordings will be maintained throughout the transit and emergency department phase of the study. These recordings will be subsequently interpreted and used to determine the validity of the SE diagnosis by the EMS system. Patients will receive standardized anticonvulsant treatment at the destination hospital, and will be monitored for seizure recurrence, cardiovascular and respiratory complications, need for subsequent intensive care, and neurological condition at discharge. Univariate and multivariate statistical comparisons will be used to determine whether pre-hospital therapy has a significant impact on the management and outcome of patients during transport and subsequent hospitalization.

癫痫持续状态（SE）每年发生在45，000至65，000人中， 美国，是一个医疗紧急情况，需要迅速， 有效干预。 尽管发展有效的 抗惊厥治疗，并认识到延长SE是 与不良的神经学结果相关，通常存在显著的 SE发作和癫痫发作成功终止之间的延迟， 常规治疗。 这是因为， 将患者运送到紧急护理设施， 患者数量，对初始抗惊厥药缺乏反应 治疗 1990年，旧金山弗朗西斯科紧急医疗服务（EMS）系统 制定了一个协议，允许医护人员静脉注射 地西泮用于现场SE治疗。 初步分析 该方案的结论表明， 地西泮治疗在急诊室的癫痫发作较少， 持续时间较短，插管次数少于 入院后开始常规抗惊厥治疗。 这些数据表明，SE的院前治疗可以简化 后续管理，并对临床过程产生有益影响 患者的结局。 尽管如此，潜在的好处和 这种治疗策略的并发症尚未在一项 严格的方式。 这是一个特别值得关注的问题，因为呼吸道 静脉注射地西泮的并发症可能很严重，来自EMS的报告 美国其他地方的系统表明， SE的治疗越来越受欢迎，尽管缺乏设计良好的 临床试验来评估它的价值。 这项拨款提案描述了一项多中心，前瞻性，随机， 一项双盲研究，旨在比较 静脉注射地西泮或劳拉西泮与安慰剂相比， 护理人员对SE中的成人患者进行现场检查。 这项研究利用了 高度集中的旧金山弗朗西斯科EMS系统， 弗朗西斯科综合医院。 医护人员会核实诊断 研究药物给药，并在转运过程中评估患者 同时与主治医生保持持续的无线电联系， SFGH的重症监护护士。 对患者的评估将 包括观察临床癫痫发作活动、 意识、生命体征、心律和脉搏氧合 血氧测定法 医护人员还将连接一个动态脑电图记录装置 在初次接触时对每例研究患者进行，并持续 在整个过境和紧急情况下， 研究的部门阶段。 这些录音将随后 解释并用于确定SE诊断的有效性 EMS系统。 患者将接受标准化抗惊厥治疗 在目的地医院，并将监测癫痫发作 复发，心血管和呼吸系统并发症，需要 随后的重症监护和出院时的神经系统状况。 将使用单变量和多变量统计比较， 确定院前治疗是否对 转运期间及随后的患者管理和结局 住院