Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.
Department of Neurology, Kassel General Hospital, Kassel, Germany.
JAMA. 2022 May 17;327(19):1899-1909. doi: 10.1001/jama.2022.4798.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
许多患有严重中风的患者气道保护反射受损，导致需要长时间进行有创机械通气。
检验早期气管切开术与标准气管切开术相比，能否改善接受机械通气的中风患者的功能预后。
设计、设置和参与者：在这项随机临床试验中，382 名接受有创通气的严重急性缺血性或出血性中风患者被随机分配（1:1）接受早期气管切开术（插管后≤5 天）或标准气管切开术（如果需要，从第 10 天开始继续进行呼吸机脱机）。患者于 2015 年 7 月 28 日至 2020 年 1 月 24 日在 26 家美国和德国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切开术策略（n = 188）或标准气管切开术（对照组）策略（n = 194）。
主要结局为 6 个月时的功能预后，基于改良 Rankin 量表评分（范围 0[最佳]至 6[最差]），分为 0（无残疾）至 4（中度残疾）与 5（重度残疾）或 6（死亡）。
在 382 名随机分组的患者中（中位年龄 59 岁；49.8%为女性），366 名（95.8%）完成了试验并获得了主要结局的随访数据（早期组 177 名患者[94.1%]；标准组 189 名患者[97.4%]）。早期气管切开组 95.2%的患者在插管后中位数 4 天（IQR，3-4 天）进行了气管切开术（主要为经皮），对照组 67%的患者在插管后中位数 11 天（IQR，10-12 天）进行了气管切开术。早期气管切开术组与对照组在 6 个月时无重度残疾（改良 Rankin 量表评分 0-4）的比例无显著差异（43.5%比 47.1%；差异，-3.6%[95%CI，-14.3%至 7.2%]；调整后的优势比，0.93[95%CI，0.60-1.42]；P = .73）。严重不良事件中，早期气管切开术组 5.0%（121 例报告事件中的 6 例）与对照组 3.4%（118 例报告事件中的 4 例）与气管切开术相关。
在接受机械通气的严重中风患者中，与标准气管切开术相比，早期气管切开术策略并未显著提高 6 个月时无重度残疾的生存率。然而，效应估计值的置信区间很宽，可能包括有临床意义的差异，因此不能排除早期气管切开术策略具有临床相关的获益或危害。
ClinicalTrials.gov 标识符：NCT02377167。
