Trial reportCritical care (London, England)2022
TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial.
Trial report in Critical care (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04412356 (Timing of Tracheotomy in Covid-19 Positive Patients), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial
Who cites it
8 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Effect of tracheotomy timing on patients receiving mechanical ventilation: A meta-analysis of randomized controlled trials.PloS one · 2024Pooled it
- Early versus late tracheostomy in critically ill COVID-19 patients.The Cochrane database of systematic reviews · 2023Pooled it
- Bayesian analysis of a systematic review of early versus late tracheostomy in ICU patients.British journal of anaesthesia · 2022Pooled it
- Early Versus Late Tracheostomy: An Umbrella Review and Meta-Analysis.Journal of clinical medicine · 2026Review
- Low Molecular Weight Heparin Dosing in Relation to Postoperative Bleeding After Tracheotomy in Patients Infected With SARS-CoV-2-A Descriptive Study.Laryngoscope investigative otolaryngology · 2025Article
- Association of early versus late tracheostomy with prognosis in hypoxic-ischaemic encephalopathy patients: A propensity-matched cohort study.Nursing in critical care · 2025Observational
- Timing of Tracheostomy in ICU Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Life (Basel, Switzerland) · 2024Review
- 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.BMC anesthesiology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCritically 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.
methodsSARS-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.
resultsOne 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.
conclusionsThe 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.
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