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Reference: JAMA 2013 May 22;309(20):2121, (level 2 [mid-level] evidence)
Tracheostomy is often performed in critically ill patients when their need for mechanical ventilation is expected to be prolonged. The optimal timing for tracheostomy is unclear, because it is based on an estimate of a patient’s ongoing ventilation requirements. However, performing the tracheostomy early (within the first week of ventilation) has become increasingly common. The TracMan trial was a large multicenter randomized trial that compared early vs. late tracheostomy in 909 patients admitted to critical care units in the United Kingdom.
Adult patients (mean age 64 years) who had been on mechanical ventilation for < 4 days and were expected to remain ventilated for at least 7 more days, were randomized to 1 of 2 tracheostomy protocols. In the early tracheostomy group, patients had the procedure within 4 days of the start of ventilation. In the late tracheostomy group, the procedure was delayed until at least 10 days and performed only if still clinically indicated. Patients were followed for 2 years.
A total of 91.9% received a tracheostomy in the early group (84.6% at < 4 days) while only 44.9% of late group had the procedure (p < 0.05). There were no significant differences in 30 day mortality (30.8% with early vs. 31.5% with late tracheostomy) or 2 year mortality (51% vs. 53.7%). The median stay in critical care was 13 days in each group. Tracheostomy-related complications (primarily bleeding requiring IV fluids or additional intervention) occurred in 5.5% vs. 7.8% in the subgroup of patients who had the procedure (5.1% vs. 3.6% overall). The trial was terminated early for futility (at 54% of planned enrollment) without a prespecified stopping rule.
These data suggest that a wait-and-see approach may help minimize unnecessary tracheostomies that do not improve clinical outcomes.
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