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重症监护病房中急性脑损伤患者的颅内压监测(SYNAPSE-ICU):一项国际、前瞻性观察性队列研究。

Intracranial pressure monitoring in patients with acute brain injury in the intensive care unit (SYNAPSE-ICU): an international, prospective observational cohort study.

机构信息

Anesthesia and Intensive Care, Policlinico San Martino, IRCCS for Oncology and Neuroscience, Genoa, Italy; Department of Surgical Science and Integrated Diagnostic, University of Genoa, Genoa, Italy.

School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy; Bicocca Bioinformatics Biostatistics and Bioimaging Center B4, School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.

出版信息

Lancet Neurol. 2021 Jul;20(7):548-558. doi: 10.1016/S1474-4422(21)00138-1.

Abstract

BACKGROUND

The indications for intracranial pressure (ICP) monitoring in patients with acute brain injury and the effects of ICP on patients' outcomes are uncertain. The aims of this study were to describe current ICP monitoring practises for patients with acute brain injury at centres around the world and to assess variations in indications for ICP monitoring and interventions, and their association with long-term patient outcomes.

METHODS

We did a prospective, observational cohort study at 146 intensive care units (ICUs) in 42 countries. We assessed for eligibility all patients aged 18 years or older who were admitted to the ICU with either acute brain injury due to primary haemorrhagic stroke (including intracranial haemorrhage or subarachnoid haemorrhage) or traumatic brain injury. We included patients with altered levels of consciousness at ICU admission or within the first 48 h after the brain injury, as defined by the Glasgow Coma Scale (GCS) eye response score of 1 (no eye opening) and a GCS motor response score of at least 5 (not obeying commands). Patients not admitted to the ICU or with other forms of acute brain injury were excluded from the study. Between-centre differences in use of ICP monitoring were quantified by using the median odds ratio (MOR). We used the therapy intensity level (TIL) to quantify practice variations in ICP interventions. Primary endpoints were 6 month mortality and 6 month Glasgow Outcome Scale Extended (GOSE) score. A propensity score method with inverse probability of treatment weighting was used to estimate the association between use of ICP monitoring and these 6 month outcomes, independently of measured baseline covariates. This study is registered with ClinicalTrial.gov, NCT03257904.

FINDINGS

Between March 15, 2018, and April 30, 2019, 4776 patients were assessed for eligibility and 2395 patients were included in the study, including 1287 (54%) with traumatic brain injury, 587 (25%) with intracranial haemorrhage, and 521 (22%) with subarachnoid haemorrhage. The median age of patients was 55 years (IQR 39-69) and 1567 (65%) patients were male. Considerable variability was recorded in the use of ICP monitoring across centres (MOR 4·5, 95% CI 3·8-4·9 between two randomly selected centres for patients with similar covariates). 6 month mortality was lower in patients who had ICP monitoring (441/1318 [34%]) than in those who were not monitored (517/1049 [49%]; p<0·0001). ICP monitoring was associated with significantly lower 6 month mortality in patients with at least one unreactive pupil (hazard ratio [HR] 0·35, 95% CI 0·26-0·47; p<0·0001), and better neurological outcome at 6 months (odds ratio 0·38, 95% CI 0·26-0·56; p=0·0025). Median TIL was higher in patients with ICP monitoring (9 [IQR 7-12]) than in those who were not monitored (5 [3-8]; p<0·0001) and an increment of one point in TIL was associated with a reduction in mortality (HR 0·94, 95% CI 0·91-0·98; p=0·0011).

INTERPRETATION

The use of ICP monitoring and ICP management varies greatly across centres and countries. The use of ICP monitoring might be associated with a more intensive therapeutic approach and with lower 6-month mortality in more severe cases. Intracranial hypertension treatment guided by monitoring might be considered in severe cases due to the potential associated improvement in long-term clinical results.

FUNDING

University of Milano-Bicocca and the European Society of Intensive Care Medicine.

摘要

背景

在急性脑损伤患者中,颅内压(ICP)监测的适应证以及 ICP 对患者预后的影响尚不确定。本研究的目的是描述全球范围内各中心急性脑损伤患者 ICP 监测的实际情况,并评估 ICP 监测和干预的适应证差异,及其与长期患者预后的关系。

方法

我们在 42 个国家的 146 个重症监护病房(ICU)进行了一项前瞻性、观察性队列研究。我们对所有年龄在 18 岁或以上、因原发性出血性卒中(包括颅内出血或蛛网膜下腔出血)或创伤性脑损伤而入住 ICU 的患者进行了评估,以确定其是否符合入选标准。我们纳入了在 ICU 入院时或脑损伤后 48 小时内意识水平改变的患者,格拉斯哥昏迷量表(GCS)眼反应评分 1 分(无睁眼)和 GCS 运动反应评分至少 5 分(不服从指令)的患者。未入住 ICU 或患有其他形式急性脑损伤的患者被排除在研究之外。通过计算中位数优势比(MOR)来量化 ICP 监测的中心间差异。我们使用治疗强度水平(TIL)来量化 ICP 干预措施的实践差异。主要终点是 6 个月死亡率和 6 个月格拉斯哥结局量表扩展版(GOSE)评分。采用倾向评分方法,使用逆概率治疗加权法来估计 ICP 监测与这 6 个月结局的关联,独立于测量的基线协变量。本研究在 ClinicalTrials.gov 上注册,编号为 NCT03257904。

结果

在 2018 年 3 月 15 日至 2019 年 4 月 30 日期间,对 4776 名患者进行了评估,其中 2395 名患者符合入选标准,包括 1287 名(54%)创伤性脑损伤患者、587 名(25%)颅内出血患者和 521 名(22%)蛛网膜下腔出血患者。患者的中位年龄为 55 岁(IQR 39-69),1567 名(65%)患者为男性。各中心之间 ICP 监测的使用存在显著差异(两个具有相似协变量的随机选择中心的患者之间的 MOR 为 4.5,95%CI 为 3.8-4.9)。有 ICP 监测的患者 6 个月死亡率(441/1318 [34%])低于未监测的患者(517/1049 [49%];p<0.0001)。在至少有一个瞳孔无反应的患者中,ICP 监测与 6 个月死亡率显著降低相关(风险比[HR]0.35,95%CI 0.26-0.47;p<0.0001),且神经功能预后更好(比值比[OR]0.38,95%CI 0.26-0.56;p=0.0025)。有 ICP 监测的患者的中位 TIL 较高(9 [IQR 7-12]),而未监测的患者的 TIL 较低(5 [3-8];p<0.0001),TIL 每增加 1 分,死亡率就会降低(HR 0.94,95%CI 0.91-0.98;p=0.0011)。

解释

各中心和国家之间 ICP 监测和 ICP 管理的使用差异很大。ICP 监测的使用可能与更强化的治疗方法相关,在更严重的情况下与 6 个月死亡率降低相关。由于可能与长期临床结果相关的改善,在严重情况下可能会考虑通过监测进行颅内高压治疗。

资助

米兰比可卡大学和欧洲重症监护医学学会。

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