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

Abstract

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 registrationNCT04412356, registered 05/24/2020. Graphic abstract

Establishment and validation of a predictive model for tracheotomy in critically ill patients and analysis of the impact of different tracheotomy timing on patient prognosis

“…There was a statistically signi cant shortening of the early tracheotomy group for the late tracheotomy group in terms of length of hospitalization, ICU stay, IMV time, and sedation time. Many previous studies have produced similar results[6, 24,25]. This is probably related to the fact that tracheotomy increases patient comfort and reduces the need for sedation [26].…”

Effect of tracheotomy timing on patients receiving mechanical ventilation: A meta-analysis of randomized controlled trials

“…409 articles were excluded due to duplication. Eventually, 21 RCTs [ 5 , 10 , 20 – 38 ] involving 3621 patients were enrolled for this meta-analysis. The flow diagram of the literature search and study selection is shown in Fig 1 .…”

When More Could Mean Less Intervention: The Tale Of Tracheostomy Timing in Critical Illness*

“…The interventions were not delivered mostly due to rapid improvement in the condition, in both the early and late tracheostomy groups. These results, together with the data presented by Villemure-Poliquin et al (5), suggest that it is unlikely to be able to observe a significant signal for beneficial effect of early tracheostomies performed within the first 10 days of mechanical ventilation in patients whose respiratory support is primarily due to nonneurologic cause (14). It is perhaps pertinent to invest time and effort into the implementation of better sedation and weaning practices and allow patients more time to be liberated from mechanical ventilation utilizing conventional endotracheal intubation, before an invasive procedure is performed on the ICU.…”

“…The study was stopped early on the recommendation of the data safety monitoring board and due to the reduction inpatient numbers. Less than half of the 150 randomized patients have actually received the intervention, and the intention to treat analysis did not show any difference between the two groups with regard to length of mechanical ventilation or other secondary outcomes (14). The interventions were not delivered mostly due to rapid improvement in the condition, in both the early and late tracheostomy groups.…”

“…Interestingly, there is only one published small randomized controlled trial, which has investigated the effect of timing of tracheostomies in COVID-19 ARDS, perhaps exemplifying the difficulties of getting equipoise in this question. The TTCOV19 study was a multicenter single-blinded open-label clinical trial, investigating if early (performed within 7 d of the start of mechanical ventilation) or late (performed at day 10 or later after the start of mechanical ventilation) has better outcomes in terms of length of mechanical ventilation (14). The study was stopped early on the recommendation of the data safety monitoring board and due to the reduction inpatient numbers.…”