Department of Neurological Surgery, University of Washington, Harborview Medical Center, Seattle, Washington 98104, USA.
Neurosurgery. 2012 Dec;71(6):1055-63. doi: 10.1227/NEU.0b013e31827276b7.
Although in the developed world the intracranial pressure (ICP) monitor is considered the standard of care for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously.
The primary focus was to conduct a high-quality, randomized, controlled trial to determine whether ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies.
Study centers were selected that routinely treated ICP based on clinical examination and computed tomography imaging using internal protocols. We randomized patients to either an ICP monitor group or an imaging and clinical examination group. Treatment decisions for the ICP monitor group are guided by ICP monitoring based on established guidelines. Treatment decisions for the imaging and clinical examination group are made using a single protocol derived from those previously being used at those centers.
There are 2 study hypotheses: (1) patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring in the care of patients with severe TBI will minimize complications and decrease length of intensive care unit stay.
This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world: the ICP monitor. A randomized, controlled trial of ICP monitoring has never been performed-a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this randomized, controlled trial will have global implications regardless of the level of development of the trauma system.
尽管在发达国家，颅内压（ICP）监测被认为是严重创伤性脑损伤（TBI）患者的标准治疗方法，但它在指导治疗决策方面的有效性从未经过严格检验。
主要目的是开展一项高质量、随机对照试验，以确定使用 ICP 监测来指导 TBI 治疗是否能改善患者预后。通过提供教育、设备和结构，该项目将增强合作研究者的研究能力，并促进早期研究中建立的合作关系。
选择那些根据临床检查和计算机断层扫描成像（使用内部方案）常规进行 ICP 治疗的研究中心。我们将患者随机分配到 ICP 监测组或成像和临床检查组。ICP 监测组的治疗决策由基于既定指南的 ICP 监测指导。成像和临床检查组的治疗决策则根据这些中心之前使用的单一方案制定。
有 2 个研究假设：（1）使用 ICP 监测仪管理急性治疗的严重 TBI 患者将有更好的预后；（2）将 ICP 监测纳入严重 TBI 患者的治疗中，将最大限度地减少并发症并缩短重症监护病房的住院时间。
这项临床试验检验了一种基于被认为是发达国家脑外伤治疗关键技术的管理方案的有效性：ICP 监测仪。从未进行过 ICP 监测的随机对照试验——这是支持 ICP 监测在 TBI 护理中作用的证据基础中的一个关键空白。因此，无论创伤系统的发展水平如何，这项随机对照试验的结果都将具有全球性意义。
