许多严重中风患者的气道保护性反射受损,导致长期有创机械通气。
探讨早期气管造口术与标准气管造口术是否能改善接受机械通气的卒中患者的功能预后。
在这项随机临床试验中,接受有创通气的382例严重急性缺血性或出血性中风患者被随机分配(1:1)到早期气管造口术(≤插管5天)或持续呼吸机撤机,如果需要,从第10天开始进行标准气管造口术。患者于2015年7月28日至2020年1月24日在美国和德国的26个神经重症监护中心进行随机分组。最终随访日期为2020年8月9日。
患者被分配到早期气管造口术策略(n=188)或标准气管造口术(对照组)策略(n=194)。
主要结果是6个月时的功能结果,基于修改后的Rankin量表得分(范围,0[最佳]至6[最差])分为0分(无残疾)至4分(中度重度残疾)与5分(重度残疾)或6分(死亡)。
在382名随机分组的患者中(中位年龄,59岁;妇女占49.8%),366例(95.8%)完成了试验,并提供了主要结局的随访数据(早期组177例患者[94.1%];标准组189例患者[97.4%])。在插管后4天的中位数中,早期气管造口术组的95.2%进行了气管造口术(主要是经皮)(IQR,3-4天),插管后中位数为11天的对照组中有67%(IQR,10-12天)。无严重残疾的比例(改良Rankin量表评分,0-4)在6个月时,早期气管造口术与对照组没有显着差异(43.5%vs47.1%;差异,-3.6%[95%CI,-14.3%至7.2%];调整后的赔率比,0.93[95%CI,0.60-1.42];P=.73)。在严重不良事件中,早期气管造口术组的5.0%(121例报告事件中的6例)与气管造口术相关的3.4%(118例报告事件中的4例)。
在接受机械通气的严重卒中患者中,早期气管造口术的策略,与气管造口术的标准方法相比,6个月时无严重残疾的生存率没有显著提高。然而,效应估计周围的宽置信区间可能包括临床上重要的差异,因此,不能排除早期气管切开术的临床相关益处或危害.
ClinicalTrials.gov标识符:NCT02377167。
Many patients with severe stroke have impaired airway protective reflexes, resulting in prolonged invasive mechanical ventilation.
To test whether early vs standard tracheostomy improved functional outcome among patients with stroke receiving mechanical ventilation.
In this randomized clinical
trial, 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation were randomly assigned (1:1) to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy if needed from day 10. Patients were randomized between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers. The final date of follow-up was August 9, 2020.
Patients were assigned to an early tracheostomy strategy (n = 188) or to a standard tracheostomy (control group) strategy (n = 194).
The primary outcome was functional outcome at 6 months, based on the modified Rankin Scale score (range, 0 [best] to 6 [worst]) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death).
Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the
trial with available follow-up data on the primary outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group). A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation (IQR, 3-4 days) and in 67% of the control group in a median of 11 days after intubation (IQR, 10-12 days). The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; difference, -3.6% [95% CI, -14.3% to 7.2%]; adjusted odds ratio, 0.93 [95% CI, 0.60-1.42]; P = .73). Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy.
Among patients with severe stroke receiving mechanical ventilation, a strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months. However, the wide confidence intervals around the effect estimate may include a clinically important difference, so a clinically relevant benefit or harm from a strategy of early tracheostomy cannot be excluded.
ClinicalTrials.gov Identifier: NCT02377167.