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TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial.
Eeg-Olofsson, Måns; Pauli, Nina; Hafsten, Louise; Jacobsson, Josephine; Lundborg, Christopher; Brink, Magnus; Larsson, Helen; Lindell, Ellen; Löwhagen, Karin; Gisslén, Magnus; Bergquist, Henrik.
  • Eeg-Olofsson M; Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. mans.eeg-olofsson@vgregion.se.
  • Pauli N; Department of Otorhinolaryngology, Head and Neck Surgery, Region Västra Götaland, Sahlgrenska University Hospital, Gröna stråket 5, 413 45, Gothenburg, Sweden. mans.eeg-olofsson@vgregion.se.
  • Hafsten L; Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  • Jacobsson J; Department of Otorhinolaryngology, Head and Neck Surgery, Region Västra Götaland, Sahlgrenska University Hospital, Gröna stråket 5, 413 45, Gothenburg, Sweden.
  • Lundborg C; Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  • Brink M; Department of Otorhinolaryngology, Head and Neck Surgery, Region Västra Götaland, Sahlgrenska University Hospital, Gröna stråket 5, 413 45, Gothenburg, Sweden.
  • Larsson H; Department of Anesthesia and Intensive Care Medicine, Institution of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  • Lindell E; Department of Anesthesia and Intensive Care Medicine, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
  • Löwhagen K; Department of Anesthesia and Intensive Care Medicine, Institution of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  • Gisslén M; Department of Anesthesia and Intensive Care Medicine, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
  • Bergquist H; Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Crit Care ; 26(1): 142, 2022 05 18.
Article in English | MEDLINE | ID: covidwho-1951298
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 registration NCT04412356 , registered 05/24/2020.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Male Language: English Journal: Crit Care Year: 2022 Document Type: Article Affiliation country: S13054-022-04005-0

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Male Language: English Journal: Crit Care Year: 2022 Document Type: Article Affiliation country: S13054-022-04005-0