TTCOV19

Critical Care

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.

TTCOV19