Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial.
Acute respiratory distress syndrome
COVID-19
Mechanical ventilation
SARS-CoV-2
Tidal volume
Ultra-low tidal volume ventilation
Ultraprotective ventilation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
11 Oct 2021
11 Oct 2021
Historique:
received:
19
03
2021
accepted:
28
09
2021
entrez:
12
10
2021
pubmed:
13
10
2021
medline:
14
10
2021
Statut:
epublish
Résumé
Acute respiratory distress syndrome (ARDS) is a severe complication of COVID-19 pneumonia, with a mortality rate amounting to 34-50% in moderate and severe ARDS, and is associated with prolonged duration of invasive mechanical ventilation. Such as in non-COVID ARDS, harmful mechanical ventilation settings might be associated with worse outcomes. Reducing the tidal volume down to 4 mL kg The VT4COVID study is a randomized, multi-centric prospective open-labeled, controlled superiority trial. Adult patients admitted in the intensive care unit with COVID-19-related mild to severe ARDS defined by a PaO The purpose of this manuscript is to provide primary publication of study protocol to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency. Enrollment of patients in the study is ongoing. ClinicalTrials.gov NCT04349618 . Registered on April 16, 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Acute respiratory distress syndrome (ARDS) is a severe complication of COVID-19 pneumonia, with a mortality rate amounting to 34-50% in moderate and severe ARDS, and is associated with prolonged duration of invasive mechanical ventilation. Such as in non-COVID ARDS, harmful mechanical ventilation settings might be associated with worse outcomes. Reducing the tidal volume down to 4 mL kg
METHODS
METHODS
The VT4COVID study is a randomized, multi-centric prospective open-labeled, controlled superiority trial. Adult patients admitted in the intensive care unit with COVID-19-related mild to severe ARDS defined by a PaO
DISCUSSION
CONCLUSIONS
The purpose of this manuscript is to provide primary publication of study protocol to prevent selective reporting of outcomes, data-driven analysis, and to increase transparency. Enrollment of patients in the study is ongoing.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT04349618 . Registered on April 16, 2020.
Identifiants
pubmed: 34635128
doi: 10.1186/s13063-021-05665-z
pii: 10.1186/s13063-021-05665-z
pmc: PMC8503716
doi:
Banques de données
ClinicalTrials.gov
['NCT04349618']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
692Informations de copyright
© 2021. The Author(s).
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