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.