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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.
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.
  • Richard JC; Université Lyon 1, Université de Lyon, Lyon, France. j-christophe.richard@chu-lyon.fr.
  • Yonis H; Medical Intensive Care Unit, Croix-Rousse Hospital, Hospices Civils de Lyon, 103 Grande Rue de la Croix Rousse, 69004, Lyon, France. j-christophe.richard@chu-lyon.fr.
  • Bitker L; CREATIS INSERM 1044 CNRS 5220, Villeurbanne, France. j-christophe.richard@chu-lyon.fr.
  • Roche S; Medical Intensive Care Unit, Croix-Rousse Hospital, Hospices Civils de Lyon, 103 Grande Rue de la Croix Rousse, 69004, Lyon, France.
  • Wallet F; Université Lyon 1, Université de Lyon, Lyon, France.
  • Dupuis C; Medical Intensive Care Unit, Croix-Rousse Hospital, Hospices Civils de Lyon, 103 Grande Rue de la Croix Rousse, 69004, Lyon, France.
  • Serrier H; CREATIS INSERM 1044 CNRS 5220, Villeurbanne, France.
  • Argaud L; Université Lyon 1, Université de Lyon, Lyon, France.
  • Thiery G; Pôle Santé Publique, Service de Biostatistique et Bioinformatique, Hospices Civils de Lyon, Lyon, France.
  • Delannoy B; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne, France.
  • Pommier C; Medical-Surgical Intensive Care Unit, Lyon-Sud Hospital, Hospices Civils de Lyon, Pierre-Bénite, France.
  • Abraham P; International Center of Research in Infectiology, INSERM U1111, CNRS UMR 5308, ENS, UCBL, Lyon University, Lyon, France.
  • Muller M; Medical Intensive Care Unit, CHU Gabriel Montpied, Clermont-Ferrand, France.
  • Aubrun F; Cellule Innovation, Délégation à la Recherche Clinique et à l'Innovation, Hospices Civils de Lyon, Lyon, France.
  • Sigaud F; Medical Intensive Care Unit, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France.
  • Rigault G; Medical Intensive Care Unit, Hopital Nord, CHU Saint-Etienne, Saint-Priest En Jarez, France.
  • Joffredo E; Medical-Surgical Intensive Care Unit, Clinique de la Sauvegarde, Lyon, France.
  • Mezidi M; Medical-Surgical Intensive Care Unit, Centre Hospitalier Saint Joseph-Saint Luc, Lyon, France.
  • Terzi N; Surgical Intensive Care Unit, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France.
  • Rabilloud M; Medical-Surgical Intensive Care Unit, Centre Hospitalier Annecy Genevois, Pringy, France.
Trials ; 22(1): 692, 2021 Oct 11.
Article in English | MEDLINE | ID: covidwho-1463262
ABSTRACT

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 PaO2/FiO2 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 11 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 principles.

DISCUSSION:

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 ClinicalTrials.gov NCT04349618 . Registered on April 16, 2020.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Observational study / Prognostic study / Randomized controlled trials / Risk factors Limits: Adult / Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: S13063-021-05665-z

Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Observational study / Prognostic study / Randomized controlled trials / Risk factors Limits: Adult / Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: S13063-021-05665-z