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Journal of the American Medical Association (05/04/22) DOI: 10.1001/jama.2022.4798
Bösel, Julian; Niesen, Wolf-Dirk; Salih, Farid; et al.
https://jamanetwork.com/journals/jama/fullarticle/2792016 

Early tracheostomy does not significantly increase survival without severe disability at 6 months for patients with severe stroke receiving mechanical ventilation, researchers report. The SETPOINT2 study, which was conducted at U.S. and German neurocritical care units between 2015 and 2020, included 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation. The patients were randomly assigned to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy, if needed from day 10. In all, 366 patients (177/188 in the early tracheostomy group and 189/194 in the standard group) completed the trial with available follow-up data on the primary outcome: functional outcome at 6 months. According to the data, 95.2% of the early tracheostomy group underwent the procedure a median of 4 days after intubation, while 67% of the standard group underwent a tracheostomy a median of 11 days after intubation. With rates of 43.5% and 47.1%, respectively, the proportion of patients who survived without severe disability (based on a modified Rankin Scale score of 0-4) at 6 months was not significantly different in the two groups. There were 121 serious adverse events in the early tracheostomy group and 118 in the standard group. Of those, 5.0% (6) and 3.4% (4), respectively, were tracheostomy-related. The authors note, "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."

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