TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial.

BACKGROUND: Critically ill COVID-19 patients may develop acute respiratory distress syndrome and the need for respiratory support, including mechanical ventilation in the intensive care unit. Previous observational studies have suggested early tracheotomy to be advantageous. The aim of this parallel, multicentre, single-blinded, randomized controlled trial was to evaluate the optimal timing of tracheotomy. METHODS: SARS-CoV-2-infected patients within the Region Västra Götaland of Sweden who needed intubation and mechanical respiratory support were included and randomly assigned to early tracheotomy (≤ 7 days after intubation) or late tracheotomy (≥ 10 days after intubation). The primary objective was to compare the total number of mechanical ventilation days between the groups. RESULTS: One hundred fifty patients (mean age 65 years, 79% males) were included. Seventy-two patients were assigned to early tracheotomy, and 78 were assigned to late tracheotomy. One hundred two patients (68%) underwent tracheotomy of whom sixty-one underwent tracheotomy according to the protocol. The overall median number of days in mechanical ventilation was 18 (IQR 9; 28), but no significant difference was found between the two treatment regimens in the intention-to-treat analysis (between-group difference: - 1.5 days (95% CI - 5.7 to 2.8); p = 0.5). A significantly reduced number of mechanical ventilation days was found in the early tracheotomy group during the per-protocol analysis (between-group difference: - 8.0 days (95% CI - 13.8 to - 2.27); p = 0.0064). The overall correlation between the timing of tracheotomy and days of mechanical ventilation was significant (Spearman's correlation: 0.39, p < 0.0001). The total death rate during intensive care was 32.7%, but no significant differences were found between the groups regarding survival, complications or adverse events. CONCLUSIONS: The potential superiority of early tracheotomy when compared to late tracheotomy in critically ill patients with COVID-19 was not confirmed by the present randomized controlled trial but is a strategy that should be considered in selected cases where the need for MV for more than 14 days cannot be ruled out. Trial registration NCT04412356 , registered 05/24/2020.

Tracheotomy in COVID-19 patients: A retrospective study on complications and timing.

OBJECTIVES: The aim of this study was to analyze the timing of tracheotomy and the duration of mechanical ventilation and stay in the intensive care unit (ICU) in patients with COVID-19 infection. Furthermore, we aimed to investigate tracheotomy complications and mortality. METHODS: Consecutive patients with COVID-19 infection admitted to the Department of Infectious Diseases in Gothenburg, Sweden were identified. Medical records were retrieved and retrospectively assessed. RESULTS: One hundred eighty-eight patients with COVID-19 infection requiring hospital care were identified. Of these, 116 patients were critically ill and intubated, and 55 patients underwent tracheotomy. The mean time from endotracheal intubation to tracheotomy was 12 days (range 5-28 days). There was a correlation between the timing of tracheotomy and the duration of mechanical ventilation, where a shorter time between intubation and tracheotomy was correlated with a shorter duration of mechanical ventilation (r .58, P < .001), and a correlation was identified between the timing of tracheotomy and the duration of ICU stay (r .52, P < .001). Perioperative hypoxemia was registered in 9% of tracheotomies performed, whereas postoperative bleeding was observed in 27% of cases, the majority of which were minor. CONCLUSIONS: This retrospective cohort study indicates that early tracheotomy is related to a reduced need for mechanical ventilation and a shorter duration of stay in the ICU in severe cases of COVID-19 disease. Complications during and after tracheotomy in this specific cohort included risk perioperative hypoxia and postoperative bleeding. Prospective randomized controlled trials would be of value to confirm these findings. LEVEL OF EVIDENCE: 4, Case series.