Germany: A strategy of early tracheostomy among patients with severe stroke receiving mechanical ventilation versus a standard approach to tracheostomy did not significantly improve functional outcomes at 6 months, according to a recent study in the Journal of the American Medical Association (JAMA). However, a clinically relevant benefit or harm from a strategy of an early tracheostomy cannot be excluded, the researchers noted.

Many patients with severe stroke have reduced airway protective reflexes leading to prolonged invasive mechanical ventilation. Julian Bösel, Department of Neurology, Kassel General Hospital, Kassel, Germany, and the team set out to determine whether early (ie, tracheostomy within 5 days of intubation) vs standard tracheostomy (ie, tracheostomy if needed after 10 days) improved functional outcome among patients with stroke receiving mechanical ventilation in a randomized clinical trial.
The study included 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation. They were randomly assigned in the ratio of 1:1 to early tracheostomy (n = 188) or ongoing ventilator weaning with standard tracheostomy if needed from day 10 (control group; n=194). Randomization was done between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers, and the final follow-up was done on August 9, 2020.
Functional outcome at 6 months based on the modified Rankin Scale score (range, 0 [best] to 6 [worst]) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death) was the primary outcome.
Based on the study, the researchers reported the following findings:
Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the trial with available follow-up data on the primary outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group).
A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation and in 67% of the control group in a median of 11 days after intubation.
The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; adjusted odds ratio, 0.93).
Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy.
"A strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months among patients with severe stroke receiving mechanical ventilation," wrote the authors.
The researchers however noted that 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 an early tracheostomy cannot be excluded.
Reference:
Bösel J, Niesen W, Salih F, et al. Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial. JAMA. Published online May 04, 2022. doi:10.1001/jama.2022.4798