Department of Medicine, Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, University of Athens Medical School, Athens, Greece; Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornell Medical College, New York, NY, USA.
First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, University of Athens Medical School, Athens, Greece.
Lancet Respir Med. 2015 Feb;3(2):150-158. doi: 10.1016/S2213-2600(15)00007-7.
Delay of tracheostomy for roughly 2 weeks after translaryngeal intubation of critically ill patients is the presently recommended practice and is supported by findings from large trials. However, these trials were suboptimally powered to detect small but clinically important effects on mortality. We aimed to assess the benefit of early versus late or no tracheostomy on mortality and pneumonia in critically ill patients who need mechanical ventilation.
We systematically searched PubMed, CINAHL, Embase, Web of Science, DOAJ, the Cochrane Library, references of relevant articles, scientific conference proceedings, and grey literature up to Aug 31, 2013, to identify randomised controlled trials comparing early tracheostomy (done within 1 week after translaryngeal intubation) with late (done any time after the first week of mechanical ventilation) or no tracheostomy and reporting on mortality or incidence of pneumonia in critically ill patients under mechanical ventilation. Our primary outcomes were all-cause mortality during the stay in the intensive-care unit and incidence of ventilator-associated pneumonia. Mortality during the stay in the intensive-care unit was a composite endpoint of definite intensive-care-unit mortality, presumed intensive-care-unit mortality, and 28-day mortality. We calculated pooled odds ratios (OR), pooled risk ratios (RR), and 95% CIs with a random-effects model. All but complications analyses were done on an intention-to-treat basis.
Analyses of 13 trials (2434 patients, 648 deaths) showed that all-cause mortality in the intensive-care unit was not significantly lower in patients assigned to the early versus the late or no tracheostomy group (OR 0·80, 95% CI 0·59-1·09; p=0·16). This result persisted when we considered only trials with a low risk of bias (511 deaths; OR 0·80, 95% CI 0·59-1·09; p=0·16; eight trials with 1934 patients). Incidence of ventilator-associated pneumonia was lower in mechanically ventilated patients assigned to the early versus the late or no tracheostomy group (691 cases; OR 0·60, 95% CI 0·41-0·90; p=0·01; 13 trials with 1599 patients). There was no evidence of a difference between the compared groups for 1-year mortality (788 deaths; RR 0·93, 95% CI 0·85-1·02; p=0·14; three trials with 1529 patients).
The synthesised evidence suggests that early tracheostomy is not associated with lower mortality in the intensive-care unit than late or no tracheostomy. However, early, compared with late or no, tracheostomy might be associated with a lower incidence of pneumonia; a finding that could question the present practice of delaying tracheostomy beyond the first week after translaryngeal intubation in mechanically ventilated patients. Nevertheless, the scarcity of a beneficial effect on long-term mortality and the potential complications associated with tracheostomy need careful consideration; thus, further studies focusing on long-term outcomes are warranted.
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目前建议在经鼻气管插管的危重症患者中大约延迟 2 周进行气管切开术，这一建议得到了来自大型试验的结果的支持。然而，这些试验在检测对死亡率有微小但临床重要影响的效果方面的效力不足。我们旨在评估在需要机械通气的危重症患者中，早期与晚期或不进行气管切开术在死亡率和肺炎方面的获益。
我们系统地检索了 PubMed、CINAHL、Embase、Web of Science、DOAJ、Cochrane 图书馆、相关文章的参考文献、科学会议录和灰色文献，截至 2013 年 8 月 31 日，以确定比较早期气管切开术（在经鼻气管插管后 1 周内进行）与晚期（在机械通气第一周后任何时间进行）或不进行气管切开术，并报告死亡率或机械通气的危重症患者肺炎发生率的随机对照试验。我们的主要结局是重症监护病房住院期间的全因死亡率和呼吸机相关性肺炎的发生率。重症监护病房住院期间的死亡率是确定的重症监护病房死亡率、假定的重症监护病房死亡率和 28 天死亡率的复合终点。我们使用随机效应模型计算了合并优势比（OR）、合并风险比（RR）和 95%置信区间（CI）。除并发症分析外，所有分析均基于意向治疗。
对 13 项试验（2434 例患者，648 例死亡）的分析表明，与晚期或不进行气管切开术相比，早期气管切开术患者的重症监护病房全因死亡率没有显著降低（OR 0.80，95%CI 0.59-1.09；p=0.16）。当我们仅考虑偏倚风险较低的试验（511 例死亡；OR 0.80，95%CI 0.59-1.09；p=0.16；8 项试验，1934 例患者）时，这一结果仍然存在。与晚期或不进行气管切开术相比，早期气管切开术患者的呼吸机相关性肺炎发生率较低（691 例；OR 0.60，95%CI 0.41-0.90；p=0.01；13 项试验，1599 例患者）。在重症监护病房住院 1 年的死亡率方面，两组之间没有证据表明存在差异（788 例死亡；RR 0.93，95%CI 0.85-1.02；p=0.14；3 项试验，1529 例患者）。
综合证据表明，与晚期或不进行气管切开术相比，早期气管切开术与重症监护病房死亡率降低无关。然而，与晚期或不进行气管切开术相比，早期气管切开术可能与肺炎发生率降低有关；这一发现可能质疑目前在机械通气患者中延迟至经鼻气管插管后第一周以上进行气管切开术的做法。然而，长期死亡率方面没有有益效果的证据以及与气管切开术相关的潜在并发症需要仔细考虑；因此，有必要进行进一步关注长期结局的研究。
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