دورية أكاديمية
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
| العنوان: | 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 |
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| المؤلفون: | Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, Rabilloud, Muriel |
| المساهمون: | Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital de la Croix-Rousse CHU - HCL, Hospices Civils de Lyon (HCL), Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Lyon Sud CHU - HCL (CHLS), CHU Gabriel Montpied Clermont-Ferrand, CHU Clermont-Ferrand, Hôpital Edouard Herriot CHU - HCL, Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E), Clinique de la Sauvegarde Lyon, Centre hospitalier Saint Joseph - Saint Luc Lyon, Centre Hospitalier Annecy-Genevois Saint-Julien-en-Genevois, Centre Hospitalier Universitaire CHU Grenoble (CHUGA), Université Grenoble Alpes (UGA), Université de Lyon, Hypoxie et PhysioPathologie (HP2), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Service de Biostatistiques Lyon |
| المصدر: | ISSN: 1745-6215 ; Trials ; https://hal.science/hal-03704468Test ; Trials, 2021, 22 (1), pp.692. ⟨10.1186/s13063-021-05665-z⟩. |
| بيانات النشر: | HAL CCSD BioMed Central |
| سنة النشر: | 2021 |
| المجموعة: | Université Jean Monnet – Saint-Etienne: HAL |
| مصطلحات موضوعية: | COVID-19, SARS-CoV-2, Acute respiratory distress syndrome, Mechanical ventilation, Ultraprotective ventilation, Ultra-low tidal volume ventilation, Tidal volume, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie |
| الوصف: | International audience ; 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 −1 of predicted body weight (PBW) to provide ultra-low tidal volume ventilation (ULTV) is an appealing technique to minimize ventilator-inducted lung injury. Furthermore, in the context of a worldwide pandemic, it does not require any additional material and consumables and may be applied in low- to middle-income countries. We hypothesized that ULTV without extracorporeal circulation is a credible option to reduce COVID-19-related ARDS mortality and duration of mechanical ventilation.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 2 /FiO 2 ratio ≤ 150 mmHg under invasive mechanical ventilation for less than 48 h, and consent to participate to the study will be eligible. Patients will be randomized into two balanced parallels groups, at a 1:1 ratio. The control group will be ventilated with protective ventilation settings (tidal volume 6 mL kg −1 PBW), and the intervention group will be ventilated with ULTV (tidal volume 4 mL kg −1 PBW). The primary outcome is a composite score based on 90-day all-cause mortality as a prioritized criterion and the number of ventilator-free days at day 60 after inclusion. The randomization list will be stratified by site of recruitment and generated using random blocks of sizes 4 and 6. Data will be analyzed using intention-to-treat principlesDiscussion The purpose of this manuscript is to provide primary publication of study protocol to prevent selective reporting of outcomes, data-driven ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/34635128; hal-03704468; https://hal.science/hal-03704468Test; https://hal.science/hal-03704468/documentTest; https://hal.science/hal-03704468/file/richard2021TRIAL.pdfTest; PUBMED: 34635128; PUBMEDCENTRAL: PMC8503716 |
| DOI: | 10.1186/s13063-021-05665-z |
| الإتاحة: | https://doi.org/10.1186/s13063-021-05665-zTest https://hal.science/hal-03704468Test https://hal.science/hal-03704468/documentTest https://hal.science/hal-03704468/file/richard2021TRIAL.pdfTest |
| حقوق: | info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.4EA82B15 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13063-021-05665-z |
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