SETPOINT2 Trial

JAMA

May 4, 2022

Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation.

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.

SETPOINT2 Trial