Managing severe TBI without ICP monitoring - guidelines development and testing

严重创伤性脑损伤（sTBI）患者颅内高压（ICH）的管理是 对他们的生存和最佳恢复至关重要。严重精神分裂症循证管理指南 创伤性脑损伤，第3版建议使用颅内压（ICP）监测仪评估ICH， 知道何时以及如何干预。不幸的是，在世界上大多数地区， 技术.这意味着大多数sTBI患者在治疗时不使用ICP监测。没有 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。 该项目的目的是为在没有ICP的情况下治疗严重TBI制定指南 监测和测试它们。该补助金即将进入第五年，需要第六和第七年才能 成功完成-特别是，有足够的能力严格测试准则。我们有 通过与一组在资源有限的环境中执业的临床医生合作，制定了一项治疗方案， 低收入国家（LMICs），并经常根据临时的 治疗方案、临床经验或两者。在2004年资助年度，我们举行了一次共识会议， 由来自14个拉丁美洲国家的临床医生参加，并制定了一项基于药物的协议， 目前正在15个资源匮乏的中心进行测试，其中一些中心之前接触过一种发展不太好的广告， 用于治疗TBI的特殊方案，以及先前没有暴露的其他方案。我们在测试 在这两组中心的治疗前/治疗后设计中，严重TBI的结局方案。在第一阶段，（现在 完成），患者根据既往RCT中制定的临时方案进行治疗（最佳TRIP 试验）或根据个体临床医生的最佳判断。在制定共识协议后，所有 研究中心接受了使用培训，并已开始实施研究阶段II，该阶段将持续到2007年。在 我们正在评估每组中心使用基于共识的方案的效果， 通过比较第一阶段和第二阶段（I期和II期）的结果， II）。最后，我们将评估基于共识的协议比特设协议对结果的影响更大。 通过比较两组站点之间从第一时段到第二时段的差异来确定方案。 如果这种新开发的方案对严重TBI的治疗有效，它可以在全球范围内使用， 在ICP监测不可用的情况下以及在高血压情况下， 选择不监控的收入中心。在中低收入国家开展此类研究的创新方法， 我们将“从零开始”开发sTBI治疗算法，并测试 增加技术或技巧。虽然对进行研究的LMIC设置有明显的价值， 研究还为高收入国家中心提供了独特而有价值的科学反馈， 这些新技术在其有效性得到严格的科学支持之前已被广泛采用。

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.