Automated Intravenous Anesthesia Delivery to Improve Outcome in Children-TIVAPeds

描述（由申请人提供）：与发达国家主要使用的吸入麻醉相比，儿童全静脉麻醉（TIVA）的结局有显著改善。例如，已经表明TIVA导致苏醒期谵妄（艾德）减少2.5倍，苏醒期谵妄是指在麻醉苏醒后儿童中常见的各种行为障碍。艾德易使儿童产生持久的记忆障碍和适应不良的行为发展。在使用吸入剂的儿科麻醉程序中，艾德的发生率可能高达40%，并且在2-6岁的儿童中最高。然而，尽管TIVA具有重要的益处，但它并没有被广泛使用，因为这种技术很难手动管理。这是由于缺乏对血液中药物浓度的直接测量，并且由于需要不断调整药物输注速率。该计划将通过对TIVAPedsTM设备进行可行性研究来解决这一问题，该设备基于对儿童大脑活动的非侵入性测量，用于自动输送TIVA。本阶段I的总体目标是探索是否有可能通过使用TIVAPeds系统实现TIVA相关结局的改善。这项为期2年的I期项目的具体目标包括在两家临床机构收集和分析儿童的临床数据。在第一次试验中，将使用我们的NeuroSENSE麻醉深度监测仪从20名接受TIVA的儿童中收集数据，TIVA由TIVAPeds闭环系统提供。该系统已获得联邦（加拿大卫生部）和机构研究伦理委员会的批准，并已成功用于涉及儿科患者的先前临床研究。第二个机构将收集接受吸入麻醉的儿童的数据，使用标准临床实践进行。将对两个研究组的数据进行比较和分析，以评估结局指标的差异。结果将用于设计关键临床研究方案，以证明TIVAPeds系统在II期研究期间的安全性和有效性。最终目标是将TIVA Peds器械商业化，以便更广泛地使用TIVA，并为大量儿科患者带来受益。

DESCRIPTION (provided by applicant): Total intravenous anesthesia (TIVA) in children offers significant improvement in outcomes in comparison to inhaled anesthesia that is predominantly used in the developed world. For example, it has been shown that TIVA results in a two-and-a-half fold reduction in emergence delirium (ED), which refers to a variety of behavioral disturbances commonly seen in children following emergence from anesthesia. ED can predispose children to lasting memory impairment and maladaptive behavior development. The incidence of ED in pediatric anesthesia procedures using inhaled agents may be as high as 40% and is highest in children aged 2-6 years. However, despite its important benefits, TIVA is not widely used since this technique is quite difficult to administer manually. This is due to the lack of a direct measure of drug concentration in the blood, and due to the need for constant adjustments in drug infusion rate. This program will address this problem by performing a feasibility study regarding outcomes of the TIVAPedsTM device for automated delivery of TIVA in children, based on noninvasive measurements of their brain activity. The overall goal of this Phase I am to explore whether it is possible to achieve improved outcomes associated with TIVA by using the TIVAPeds system. The Specific Aims of this 2-year Phase I program include collection and analysis of clinical data in children at two clinical institutions. At the first insitution, data will be collected from 20 children undergoing TIVA delivered by the TIVAPeds closed-loop system using our NeuroSENSE depth-of-anesthesia monitor. This system has already received Federal (Health Canada) and institution's Research Ethics Board approval, and has been successfully used in prior clinical studies involving pediatric patients. The second institution wil collect data from children receiving inhaled anesthesia, delivered using standard clinical practice. The data from the two study arms will be compared and analyzed to assess differences in outcome measures. Results will be used for the design of a pivotal clinical study protocol, for demonstrating safety and efficacy of the TIVAPeds system during the Phase II effort. The ultimate objective is to commercialize the TIVAPeds device in order to enable wider use of TIVA and bring its benefits to a large number of pediatric patients.