Managing severe TBI without ICP monitoring - guidelines development and testing

在没有 ICP 监测的情况下管理严重的 TBI - 指南的制定和测试

基本信息

批准号：
9309443
负责人：
RANDALL M CHESNUT
金额：
$ 54.34万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-30 至 2019-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9309443
关键词：
Adopted Adult Algorithms Amnesia Area Auditory Benchmarking Clinical Clinical Treatment Collection Consensus Consensus Development Country Data Data Collection Decision Making Development Equation Evaluation Exposure to Feedback Funding Glasgow Coma Scale Glasgow Outcome Scale Grant Guidelines Heart Income Individual Injury Intelligence Intervention Intracranial Hypertension Intracranial Pressure Judgment Latin American Life Literature Measures Monitor Observational Study Outcome Patient-Focused Outcomes Patients Phase Process Protein Structure Initiative Protocols documentation Randomized Controlled Trials Recovery Research Resources Running Site South American Techniques Technology Testing Training Traumatic Brain Injury Treatment Protocols Verbal Learning Work World Bank acronyms base comparative effectiveness design effective therapy evidence based guidelines experience improved outcome indexing innovation low and middle-income countries mortality neurobehavioral new technology phase 2 study pressure processing speed prospective protocol development satisfaction symposium

项目摘要

Management of intracranial hypertension (ICH) in patients with severe traumatic brain injury (sTBI) is crucial to their survival and optimal recovery. The evidence-based Guidelines for the Management of Severe Traumatic Brain Injury, 3rd Edition recommends use of intracranial pressure (ICP) monitors to assess ICH and know when and how to intervene. Unfortunately in most areas of the world there is no access to ICP monitor technology. This means that most people with sTBI are treated without use of ICP monitoring. There are no Guidelines and no literature on how to treat sTBI without use of ICP monitors. The objective of this project is to create guidelines for the treatment of severe TBI in the absence of ICP monitoring and test them. The grant is about to enter its 5th year and requires a 6th and 7th year in order to be completed successfully – specifically, with sufficient power to rigorously test the guidelines. We have developed a treatment protocol by working with a team of clinicians who practice in resource-limited environ- ments in low-to-middle income countries (LMICs) and routinely make decisions based either on an ad hoc treatment protocol, their clinical experience, or both. During grant year 04 we held a consensus conference attended by clinicians from 14 Latin American countries and developed a Consensus-Based protocol that is now being tested in 15 resource-poor centers, some of which have prior exposure to a less well developed ad hoc protocol for treatment of TBI, and others that have not had prior exposure. We are testing the influence of the protocol on outcomes of severe TBI in a before/after design in these two sets of centers. In Phase I, (now complete), patients were treated according to an ad hoc protocol developed in a prior RCT (the BEST TRIP Trial) or according to individual clinician best judgment. Following development of the consensus protocol, all sites were trained in its use, and have begun implementing study Phase II which will last through year 07. In each set of centers we are evaluating the effect of using the consensus-based protocol compared to either no protocol or the ad hoc protocol by comparing the outcomes in the first and second periods (Phase I and Phase II). Finally, we will evaluate how much more the consensus-based protocol effects outcome than the ad hoc protocol by comparing the difference from the first to the second period between the two sets of sites. If this newly developed protocol is effective for treatment of severe TBI, it could be used globally to improve outcomes for sTBI patients in situations where ICP monitoring is not available as well as in high income centers that choose not to monitor. The innovative approach of doing such research in LMICs allows us to work “from the ground up” in developing sTBI treatment algorithms and testing the marginal benefits of added technology or techniques. Although of clear value to the LMIC settings where the research is done, such studies also provide unique and valuable scientific feedback to High Income Country centers where many of these new technologies have been widely adopted in advance of rigorous scientific support for their efficacy.

严重创伤性脑损伤（sTBI）患者颅内高压（ICH）的治疗对他们的生存和最佳康复至关重要。创伤性脑损伤，第 3 版建议使用颅内压 (ICP) 监测仪来评估 ICH 和知道何时以及如何进行干预不幸的是，世界上大多数地区都无法使用 ICP 监测仪。这意味着大多数 sTBI 患者在治疗时无需使用 ICP 监测。关于如何在不使用 ICP 监测仪的情况下治疗 sTBI 的指南和文献。该项目的目标是制定在没有 ICP 的情况下治疗严重 TBI 的指南监督和测试它们即将进入第五年，需要第六年和第七年才能实现。成功完成——具体来说，我们有足够的能力来严格测试指南。通过与在资源有限的环境中练习的弟子团队合作制定了治疗方案中低收入国家 (LMIC) 的决策和日常决策基于临时决策治疗方案、他们的临床经验，或两者兼而有之。在第 04 年的资助期间，我们召开了一次共识会议。 14 个拉丁美洲国家参加并制定了一项基于共识的协议目前正在 15 个资源匮乏的中心进行测试，其中一些中心之前曾接触过开发欠佳的广告 TBI 治疗的特殊方案以及其他先前未接触过的方案我们正在测试其影响。关于这两组中心的严重 TBI 治疗前后设计的结果的协议（现在处于第一阶段）。完成），患者根据之前的 RCT 中制定的临时方案进行治疗（BEST TRIP 试验）或根据个体临床医生的最佳判断制定共识方案。站点接受了使用培训，并已开始实施第二阶段研究，该阶段将持续到 07 年。我们正在对每组中心评估使用基于共识的协议与不使用基于共识的协议的效果通过比较第一阶段和第二阶段（第一阶段和第二阶段）的结果来确定协议或临时协议 II) 最后，我们将评估基于共识的协议比临时协议对结果的影响有多大。通过比较两组站点之间第一阶段和第二阶段的差异来制定协议。如果这个新开发的方案对治疗严重 TBI 有效，那么它可以在全球范围内使用在无法进行 ICP 监测的情况下以及在高浓度情况下改善 sTBI 患者的预后选择不进行监测的收入中心可以采用在中低收入国家进行此类研究的创新方法。我们“从头开始”开发 STBI 治疗算法并测试边际效益增加的技术或技巧虽然对进行研究的中低收入国家具有明显的价值，但研究还为高收入国家中心提供了独特且有价值的科学反馈，其中许多这些新技术在其功效得到严格的科学支持之前已被广泛采用。