SETPOINT2 Trial

What was the research question?

• Does early tracheostomy in patients with severe stroke receiving mechanical ventilation improve functional outcome compared to standard approach?

How did they do it?

• ·A randomized controlled trial in 26 neurocritical care centers in the US and Germany.

• 382 patients with severe acute ischemic or hemorrhagic stroke on invasive mechanical ventilation.

• Randomized in 1:1 assignment to receive early tracheostomy within the first 5 days of intubation (188 patients) or standard tracheostomy from day 10 if needed after ongoing ventilator weaning (194 patients).

What did they find?

• Tracheostomy was performed in 95.2% of the early group patients at a median of 4 days after intubation compared to 67% of the late tracheostomy group with a median of 11 days after intubation.

• The primary outcome of 6-month functional status without severe disability (a modified      Rankin Scale score ≤ 4) was not significantly different between early and standard tracheostomy groups (43.5% vs 47.1%, odds ratio, 0.93 [95% CI, 0.60-1.42]; P = .73).

• Serious adverse events were not different between the two groups (5.0% vs. 3.4%).

Are there any limitations?

• Potential for bias as the staff could not be blinded.

• The study was powered to detect a difference of 15% in outcome, any smaller difference would have required larger number of patients.

• No standardized weaning protocols.

• There is heterogeneity in population of the trial with 3 different stroke subtypes with important differences in outcomes.

• Results cannot be generalized to longer duration more than 11 days (the median in the control group).

What does it mean?

• Early tracheostomy did not change the 6-month functional outcome without severe disability of patients with severe stroke compared to standard approach. However, there was a wide confidence interval in the effect estimate.