For the study, researchers sought to determine if early tracheostomy vs conventional tracheostomy improves functional outcomes in stroke patients receiving mechanical ventilation. In this randomized clinical research, 382 patients with severe acute ischemic or hemorrhagic stroke who required invasive ventilation were randomly allocated (1:1) to early tracheostomy (5 days of intubation) or continued ventilator weaning with routine tracheostomy if necessary from day 10. Patients were randomized at 26 neurocritical care sites in the United States and Germany between July 28, 2015, and January 24, 2020. The last follow-up date was August 9, 2020. Patients were randomly randomized to either an early tracheostomy (n=188) or a regular tracheostomy (n=194) method. The primary outcome was the functional result at 6 months, as measured by the modified Rankin Scale score (range, 0 [best] to 6 [worst]), which was dichotomized to a score of 0 (no disability) to 4 (moderately severe impairment) vs 5 (severe disability) or 6 (no disability) (death).
About 366 (95.8%) of the 382 participants randomized (median age, 59 years; 49.8% women) completed the study with accessible follow-up data on the main outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group). A tracheostomy (mostly percutaneous) was done in 95.2% of the early tracheostomy group 4 days after intubation (IQR, 3-4 days) and in 67% of the control group 11 days after intubation (IQR, 10-12 days). At 6 months, the proportion of early tracheostomy patients without severe disability (modified Rankin Scale score, 0-4) was not significantly different from the control group (43.5% vs 47.1%; difference, −3.6% [95% CI, −14.3% to 7.2%]; adjusted odds ratio, 0.93 [95% CI, 0.60-1.42]; P = .73). In the early tracheostomy group, 5.0% (6 of 121 reported occurrences) were connected to tracheostomy, while 3.4% (4 of 118 recorded events) were not.
A strategy of early tracheostomy, compared to a typical approach to tracheostomy, did not substantially enhance the rate of survival without severe impairment at 6 months in patients with severe stroke receiving mechanical ventilation. However, because the broad CIs surrounding the impact estimate may contain a clinically significant difference, a clinically relevant benefit or harm from an early tracheostomy technique cannot be ruled out.