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Effect of early versus late or no tracheostomy on mortality and pneumonia of critically ill patients receiving mechanical ventilation: a systematic review and meta-analysis

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Summary

Background

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.

Methods

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.

Findings

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).

Interpretation

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.

Funding

None.

Introduction

A substantial proportion (up to a third) of patients who receive mechanical ventilation for more than 48 h undergo tracheostomy.1, 2 Perceived benefits of tracheostomy include airway security, enhanced patient comfort, and easier weaning from mechanical ventilation, but the procedure is not risk free. Thus, patients who need mechanical ventilation often undergo translaryngeal intubation for an initial period of time, after which a tracheostomy is undertaken. However, optimum timing for the placement of a tracheostomy remains a challenging question.

In the past few years, investigators of large trials addressed this question and reported that timing of tracheostomy might not affect clinical outcomes.3, 4, 5 Accordingly, most experts support the wait-and-see strategy—ie, the delay of tracheostomy placement until day 106 or even day 157, 8 of mechanical ventilation. However, even the largest and most recent of the above mentioned contributions did not achieve its intended sample size.3 Because of the potentially modest benefits of early tracheostomy and the methodological challenges to design and undertake such trials (eg, recruitment rates), any one trial might be unlikely to provide convincing evidence of the effectiveness of the intervention. A carefully done meta-analysis of trials could address this issue;9 it could restrict the likelihood of type II error by increasing sample size, and uncover the benefit (if any) of the intervention. We did a systematic review and meta-analysis to investigate whether early tracheostomy has any benefit compared with late or no tracheostomy in terms of mortality and pneumonia in critically ill patients who need mechanical ventilation.

Section snippets

Search strategy and selection criteria

We undertook the systematic review and meta-analysis in accordance with recommendations of the Cochrane Handbook for Systematic Reviews of Interventions.10 We reported the systematic review and the meta-analysis in accordance with the PRISMA Statement.11 The review protocol is available online.

We systematically searched PubMed, CINAHL, Embase, Web of Science, Directory of Open Access Journals, and the Cochrane Central Register of Controlled Trials from database inception to Aug 31, 2013. We

Results

Figure 1 shows the flow diagram for study selection. We included 16 trials3, 4, 5, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 in the systematic review. One of these trials27 was a conference abstract that mentioned significant difference in mortality (but not in pneumonia) in favour of early versus late tracheostomy; however, it was not included in the meta-analysis because it did not provide specific numbers and we could not contact its investigators.27 Thus, 15 trials were included in

Discussion

The synthesised evidence suggests that early, compared with late or no, tracheostomy is not significantly associated with lower mortality in the intensive-care unit, but might be associated with lower incidence of ventilator-associated pneumonia.

Our finding for intensive-care-unit mortality is in line with those of recent trials in which early tracheostomy offered no survival benefit compared with postponing tracheostomy for at least 10 days after the start of mechanical ventilation.3, 4, 5

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