Critical Care Journal
May 18, 2022
Timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial.
What was the research question?
Does early tracheostomy reduce the total number of ventilator days compared to late tracheostomy in COVID-19 critically ill patients requiring mechanical ventilation?
How did they do it?
A multicenter, parallel, single-blinded, randomized controlled trial in Sweden.
A total of 150 adult patients with SARS-CoV-2 infection and respiratory failure requiring mechanical ventilation were randomized to undergo early tracheotomy (≤ 7 days after intubation) (72 patients) or late tracheotomy (≥ 10 days after intubation) (78 patients).
The primary outcome is the total number of mechanical ventilation days.
What did they find?
Only 61 patients underwent tracheostomy as per protocol (27 patients in the early tracheostomy group compared to 34 patients in the late tracheostomy group).
There was no significant difference in the mean number of mechanical ventilation days in the early tracheostomy group compared to the late tracheostomy group in the intent-to-treat analysis (ITT) (19.6 vs. 21.1 days, P=0.5). However, there was a significantly reduced number of mechanical ventilation days in the early tracheotomy group compared to the late tracheostomy group in the per-protocol analysis (PP) (22.3 vs. 30.3 day, p = 0.0064).
Mortality, days in the ICU, number of days with sedation, or complications were not significantly different between the two groups.
Are there any limitations?
80% of patients were from one hospital and the remaining from two other hospitals which limit the generalizability of the study.
A relatively high rate of patients did not receive tracheostomy (32%).
PP analysis tends to overestimate the effect size as compared to ITT analysis that may underestimate the effect size.
The study has the potential of type II error and is under-powered as it would have required 1000 patients in each arm to obtain statistical significance of 80% and p < 0.05.
What does it mean?
The study does not confirm that early tracheostomy improves ventilator days as it is under-powered, but early tracheostomy is a strategy that should be considered in selected cases where the need for mechanical ventilation of more than 14 days is anticipated.