Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial.

BACKGROUND AND PURPOSE Optimal timing of tracheostomy in ventilated patients with severe stroke is unclear. We aimed to investigate feasibility, safety, and potential advantages of early tracheostomy in these intensive care unit (ICU) patients. METHODS This prospective, randomized, parallel-group, controlled, open, and outcome-masked pilot trial was conducted in neurological/neurosurgical ICUs of a university hospital. Patients with severe ischemic or hemorrhagic stroke and an estimated need for at least 2 weeks of ventilation were randomized to either early tracheostomy (within day 1-3 from intubation; early) or to standard tracheostomy (between day 7-14 from intubation if extubation could not be achieved or was not feasible; standard). The primary outcome was length of stay in the ICU; secondary outcomes were diverse aspects of the ICU course. RESULTS Sixty patients were randomized and analyzed. No differences were observed with regard to the primary outcome length of stay in the ICU (median 18 [interquartile range 16-28] versus 17 [interquartile range 13-22] days, median difference: 1 [-2 to 6]; P=0.38) or to most secondary outcomes, including adverse effects. Instead, use of sedatives (62% versus 42% of ICU stay, median difference 17.5 [3.3-29.2]; P=0.02), ICU mortality (ICU deaths 3 [10%] versus 14 [47%]; P<0.01) and 6-month mortality (deaths 8 [27%] versus 18 [60%]; P=0.02) were lower in the early group than in the standard group, respectively. CONCLUSIONS Early tracheostomy in ventilated intensive care stroke patients is feasible, and safe, and presumably reduces sedation need. Whether the suggested benefits in mortality and outcome truly exist has to be determined by a larger multicenter trial.