Capacity Building for Decompressive Craniotomy in Colombia

描述（由申请人提供）：在低收入到中等收入国家（LMIC），遭受严重创伤（包括创伤性脑损伤（TBI））的患者的死亡概率是高收入国家（HIC）患者的2到6倍。这种差异与技术资源水平较低有关，包括颅内压（ICP）监测。严重TBI（sTBI）患者死亡和残疾的主要风险因素是脑肿胀导致的ICP升高。去骨瓣减压术（DC）是一种神经外科手术，其中大部分颅骨被移除，以允许更多的空间用于肿胀的大脑扩张，而不会进一步增加ICP。《严重创伤性脑损伤管理指南》中的循证治疗方案依赖于ICP监测来了解何时以及如何干预。一个尚未回答的重要问题是，DC是否以及在哪些患者中应该早期（受伤后6-12小时内）或延迟（受伤后12 - 48小时，以及重症监护室[ICU]医疗失败后）进行。目前，正在进行几项随机对照试验（RCT）来回答这个问题，但不幸的是，这些试验仅针对接受ICP监测的患者。然而，大多数发展中国家没有比较方案监测器。因此，需要标准化的方法来在没有ICP监测器的环境中对TBI进行临床评估，并且需要识别有效的、低成本的、协议驱动的治疗干预措施以及建立进行关于TBI的研究的能力。哥伦比亚是一个创伤性脑损伤发病率非常高的国家，其卫生基础设施随时可以促进神经创伤方面的能力建设 临床研究我们建议通过在三个创伤中心进行试点研究，在其中我们将开发和引入sTBI患者护理算法，来发展哥伦比亚正在进行的神经创伤研究的能力。该算法将包括一个检查表， 选择早期DC的患者，并制定术中和术后护理方案。我们将 比较在引入该算法之前和之后接受治疗的sTBI患者的结局，这将提供初步数据，以支持在没有ICP监测器的临床环境中关于DC的RCT。

DESCRIPTION (provided by applicant): In Low-to-Middle Income Countries (LMICs), the probability of death for patients sustaining a severe trauma, including traumatic brain injury (TBI), is two to six times greater than for patients in High Income Countries (HICs). This disparity is associated with lower levels of technical resources, including monitoring of intracranial pressure (ICP). A main risk factor for death and disability in severe TBI (sTBI) patients is increased ICP due to brain swelling. Decompressive craniectomy (DC) is a neurosurgical procedure in which a large portion of the skull is removed to allow more space for a swelling brain to expand without further increasing ICP. The evidence- based treatment options in The Guidelines for the Management of Severe Traumatic Brain Injury rely on ICP monitoring to know when and how to intervene. An important question, yet unanswered, is whether, and in which patients, DC should be performed early (within 6-12 hours post-injury), or delayed (12 to 48 hours post-injury, and after Intensive Care Unit [ICU] medical treatment fails). Currently, several randomized controlled trials (RCTs) are being conducted to answer that question, but unfortunately, only in patients who have ICP monitoring. However, most of the developing world does not have access to ICP monitors. Thus, there is a need for standardized approaches to clinical assessment of TBI in environments without ICP monitors, and for the identification of effective, low-cost, protocol-driven interventions for treatment as well as to create of capacity to conduct research about TBI. Colombia, a country with a very high incidence of TBI, has a health infrastructure ready to facilitate capacity building for neurotrauma clinical research. We propose to develop capacity for ongoing neurotrauma research in Colombia, by conducting a pilot study in three trauma centers in which we will develop and introduce an algorithm for the care of sTBI patients. The algorithm will consist of a checklist for selection of patients for early DC and a protocol for their inter- and post-operative care. We will compare outcomes for sTBI patients treated before and after the introduction of the algorithm, which will provide preliminary data to support an RCT about DC in clinical settings without ICP monitors.