Forsyth Rob J, Raper Joseph, Todhunter Emma
Institute of Neuroscience, Newcastle University, Royal Victoria Infirmary, Newcastle upon Tyne, Tyne & Wear, UK, NE1 4LP.
Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD002043. doi: 10.1002/14651858.CD002043.pub3.
We know that the brain damage resulting from traumatic and other insults is not due solely to the direct consequences of the primary injury. A significant and potentially preventable contribution to the overall morbidity arises from secondary hypoxic-ischaemic damage. Brain swelling accompanied by raised intracranial pressure (ICP) prevents adequate cerebral perfusion with well-oxygenated blood.Detection of raised ICP could be useful in alerting clinicians to the need to improve cerebral perfusion, with consequent reductions in brain injury.
To determine whether routine ICP monitoring in severe coma of any cause reduces the risk of all-cause mortality or severe disability at final follow-up.
We searched the Cochrane Injuries Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL Plus, ISI Web of Science (SCI-EXPANDED & CPCI-S), clinical trials registries and reference lists. We ran the most recent search on 22 May 2015.
All randomised controlled studies of real-time ICP monitoring by invasive or semi-invasive means in acute coma (traumatic or non-traumatic aetiology) versus clinical care without ICP monitoring (that is, guided only by clinical or radiological inference of the presence of raised ICP).
Two authors (ET and RF) worked independently to identify the one study that met inclusion criteria. JR and RF independently extracted data and assessed risk of bias. We contacted study authors for additional information, including details of methods and outcome data.
One randomized controlled trial (RCT) meeting the selection criteria has been identified to date.The included study had 324 participants. We judged risk of bias to be low for all categories except blinding of participants and personnel, which is not feasible for this intervention. There were few missing data, and we analysed all on an intention-to-treat basis.Participants could be 13 years of age or older (mean age of sample 29; range 22 to 44), and all had severe traumatic brain injury, mostly due to traffic incidents. All were receiving care within intensive care units (ICUs) at one of six hospitals in either Bolivia or Ecuador. Investigators followed up 92% of participants for six months or until death. The trial excluded patients with a Glasgow Coma Score (GCS) less than three and fixed dilated pupils on admission on the basis that they had sustained brain injury of an unsalvageable severity.The study compared people managed using either an intracranial monitor or non-invasive monitoring (imaging and clinical examination) to identify potentially harmful raised intracranial pressure. Both study groups used imaging and clinical examination measures.Mortality at six months was 56/144 (39%) in the ICP-monitored group and 67/153 (44%) in the non-invasive group.Unfavourable outcome (defined as death or moderate to severe disability at six months) as assessed by the extended Glasgow Outcome Scale (GOS-E) was 80/144 (56%) in the ICP-monitored group and 93/153 (61%) in the non-invasive group.Six percent of participants in the ICP monitoring group had complications related to the monitoring, none of which met criteria for being a serious adverse event. There were no complications relating to the non-invasive group.Other complications and adverse events were comparable between treatment groups, 70/157 (45%) in the ICP-monitored group and 76/167 (46%) in the non-invasive group.Late mortality in both the monitored and non-invasive groups was high, with 35% of deaths occurring > 14 days after injury. The authors comment that this high late mortality may reflect inadequacies in post-ICU services for disabled survivors requiring specialist rehabilitation care.
AUTHORS' CONCLUSIONS: The data from the single RCT studying the role of routine ICP monitoring in acute traumatic coma fails to provide evidence to support the intervention.Research in this area is complicated by the fact that RCTs necessarily assess the combined impact of measurement of ICP with the clinical management decisions made in light of this data. Future studies will need to assess the added value of ICP data alongside other information from the multimodal monitoring typically performed in intensive care unit settings. Additionally, even within traumatically acquired brain injury (TBI), there is great heterogeneity in mechanisms, distribution, location and magnitude of injury, and studies within more homogeneous subgroups are likely to be more informative.
我们知道,创伤性及其他损伤所导致的脑损伤并非仅由原发性损伤的直接后果所致。继发性缺氧缺血性损伤对总体发病率有显著且可能可预防的影响。脑肿胀伴颅内压(ICP)升高会妨碍用充分氧合的血液进行充分的脑灌注。检测ICP升高可能有助于提醒临床医生有必要改善脑灌注,从而减少脑损伤。
确定对任何原因导致的严重昏迷进行常规ICP监测是否能降低最终随访时全因死亡率或严重残疾的风险。
我们检索了Cochrane损伤组专业注册库、Cochrane对照试验中央注册库(CENTRAL)、MEDLINE(OvidSP)、EMBASE(OvidSP)、CINAHL Plus、ISI科学网(SCI - EXPANDED & CPCI - S)、临床试验注册库及参考文献列表。我们于2015年5月22日进行了最新检索。
所有关于通过有创或半有创手段对急性昏迷(创伤性或非创伤性病因)进行实时ICP监测的随机对照研究,与未进行ICP监测的临床护理(即仅通过临床或影像学推断ICP升高来指导)进行比较。
两位作者(ET和RF)独立工作以确定符合纳入标准的一项研究。JR和RF独立提取数据并评估偏倚风险。我们联系了研究作者以获取更多信息,包括方法细节和结局数据。
迄今为止已确定一项符合入选标准的随机对照试验(RCT)。纳入研究有324名参与者。除参与者和人员的盲法这一类别外,我们判断所有类别的偏倚风险均较低,因为该干预措施无法实现盲法。缺失数据很少,我们基于意向性分析对所有数据进行了分析。参与者年龄可在13岁及以上(样本平均年龄29岁;范围22至44岁),且均有严重创伤性脑损伤,主要因交通事故所致。所有患者均在玻利维亚或厄瓜多尔的六家医院之一的重症监护病房(ICU)接受治疗。研究者对92%的参与者进行了为期六个月的随访或直至死亡。该试验排除了入院时格拉斯哥昏迷评分(GCS)低于3分且瞳孔固定散大的患者,因为他们的脑损伤严重程度无法挽救。该研究比较了使用颅内监测器或非侵入性监测(影像学和临床检查)来识别潜在有害的颅内压升高的患者的治疗情况。两个研究组均使用了影像学和临床检查措施。ICP监测组六个月时的死亡率为56/144(39%),非侵入性组为67/153(44%)。根据扩展格拉斯哥预后量表(GOS - E)评估,ICP监测组六个月时的不良结局(定义为死亡或中度至重度残疾)为80/144(56%),非侵入性组为93/153(61%)。ICP监测组6%的参与者出现与监测相关的并发症,均不符合严重不良事件的标准。非侵入性组无并发症。治疗组之间的其他并发症和不良事件相当,ICP监测组为70/157(45%),非侵入性组为76/167(46%)。监测组和非侵入性组的晚期死亡率均较高,35%的死亡发生在受伤14天之后。作者评论说,这种高晚期死亡率可能反映了为需要专科康复护理的残疾幸存者提供的ICU后服务存在不足。
这项研究常规ICP监测在急性创伤性昏迷中作用的单一RCT数据未能提供支持该干预措施的证据。该领域的研究因以下事实而变得复杂:RCT必然会评估ICP测量与根据这些数据做出的临床管理决策的综合影响。未来的研究需要评估ICP数据与重症监护病房环境中通常进行的多模式监测的其他信息相比的附加价值。此外,即使在创伤性脑损伤(TBI)范围内,损伤的机制、分布、位置和严重程度也存在很大异质性,在更同质的亚组内进行研究可能会提供更多信息。