{
  "abstract": "Introduction Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.Methods and analysis The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.Ethics and dissemination Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.Trial registration number NCT03963622.",
  "authors": [
    {
      "affiliations": [
        "Médecine Intensive et Réanimation, CHU Poitiers, Poitiers, France",
        "INSERM CIC1402, IS-ALIVE research group, Université de Poitiers, Poitiers, France"
      ],
      "name": "Rémi Coudroy"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Division of Respirology and Critical Care, Department of Medicine, University Health Network, Toronto, Ontario, Canada"
      ],
      "name": "Irene Telias"
    },
    {
      "affiliations": [
        "Intensive Care Volwassenen, Erasmus MC, Rotterdam, Netherlands"
      ],
      "name": "Annemijn Jonkman"
    },
    {
      "affiliations": [
        "Médecine Intensive et Réanimation, CHU Poitiers, Poitiers, France",
        "INSERM CIC1402, IS-ALIVE research group, Université de Poitiers, Poitiers, France"
      ],
      "name": "Arnaud W Thille"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Hôpital Européen Georges Pompidou, Paris, France",
        "UMR970, Paris Centre of Cardiovascular Research, Paris, France"
      ],
      "name": "Jean‑Luc Diehl"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Hôpital Européen Georges Pompidou, Paris, France",
        "UMR970, Paris Centre of Cardiovascular Research, Paris, France"
      ],
      "name": "Nicolas Péron"
    },
    {
      "affiliations": [
        "St Michael’s Hospital Keenan Research Centre for Biomedical Science, Toronto, Ontario, Canada"
      ],
      "name": "Matthew Ko"
    },
    {
      "affiliations": [
        "Equipe d’Anesthésie Réanimation, Cholet Hospital Center, Cholet, France"
      ],
      "name": "Anne-Astrid Bourion"
    },
    {
      "affiliations": [
        "Servicio de Kinesiología, Unidad de Medicina Crítica y Terapia Intensiva, Complejo Médico de la Policia Federal Argentina Churruca Visca, Buenos Aires, Argentina"
      ],
      "name": "Norberto Tiribelli"
    },
    {
      "affiliations": [
        "Servicio de Kinesiología, Unidad de Medicina Crítica y Terapia Intensiva, Complejo Médico de la Policia Federal Argentina Churruca Visca, Buenos Aires, Argentina"
      ],
      "name": "Sebastián Fredes"
    },
    {
      "affiliations": [
        "Unidad de Cuidados Especiales, Sanatorio Mater Dei, Buenos Aires, Argentina"
      ],
      "name": "Magalí Gutiérrez"
    },
    {
      "affiliations": [
        "Unidad de Cuidados Especiales, Sanatorio Mater Dei, Buenos Aires, Argentina"
      ],
      "name": "Augustín Manchado Bruno"
    },
    {
      "affiliations": [
        "Unidad de Cuidados Intensivos, Sanatorio Anchorena, Buenos Aires, Argentina"
      ],
      "name": "Daniela N Vasquez"
    },
    {
      "affiliations": [
        "Servicio de Kinesiología y Rehabilitación, Unidad de Cuidados Intensivos, Sanatorio Anchorena, Buenos Aires, Argentina"
      ],
      "name": "Romina A Pratto"
    },
    {
      "affiliations": [
        "Servicio de Rehabilitación, Unidad de Terapia Intensiva, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina"
      ],
      "name": "Gustavo A Plotnikow"
    },
    {
      "affiliations": [
        "Servicio de Rehabilitación, Unidad de Terapia Intensiva, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina"
      ],
      "name": "Facundo Bianchini"
    },
    {
      "affiliations": [
        "Villa Lynch, Sanatorio Anchorena San Martin, Buenos Aires, Argentina",
        "CABA, Quemados Hospital, Buenos Aires, Argentina"
      ],
      "name": "Matias Accoce"
    },
    {
      "affiliations": [
        "Villa Lynch, Sanatorio Anchorena San Martin, Buenos Aires, Argentina",
        "Hospital de Gastroenterología Dr Carlos Bonorino Udaondo, Buenos Aires, Argentina"
      ],
      "name": "Javier Dorado"
    },
    {
      "affiliations": [
        "Department of Translational Medicine, University of Ferrara, Ferrara, Italy"
      ],
      "name": "Savino Spadaro"
    },
    {
      "affiliations": [
        "Department of Translational Medicine, University of Ferrara, Ferrara, Italy"
      ],
      "name": "Riccardo La Rosa"
    },
    {
      "affiliations": [
        "Service de Réanimation Médicale, CHU de Brest, Brest, France"
      ],
      "name": "Gwénael Prat"
    },
    {
      "affiliations": [
        "Réanimation Médicale, CHU de Brest, Brest, France"
      ],
      "name": "Pierre Bailly"
    },
    {
      "affiliations": [
        "Réanimation Polyvalente, Centre Hospitalier Bretagne Atlantique, Vannes, France"
      ],
      "name": "Agathe Delbove"
    },
    {
      "affiliations": [
        "Vall d’Hebron University Hospital, Barcelona, Spain"
      ],
      "name": "Andrés Pacheco-Reyes"
    },
    {
      "affiliations": [
        "Servei de Medicina Intensiva, Bellvitge University Hospital, L’Hospitalet de Llobregat, Spain",
        "Ciber Enfermedades Respiratorias (Ciberes), Instituto de Salud Carlos III, Madrid, Spain"
      ],
      "name": "Oriol Roca"
    },
    {
      "affiliations": [
        "Service de Réanimation Médicale, GHRMSA, Mulhouse, France"
      ],
      "name": "Khaldoun Kuteifan"
    },
    {
      "affiliations": [
        "Médecine Intensive-Réanimation, CHU de Lille, Lille, France",
        "CNRS, UMR 8576 - UGSF, Université de Lille, Lille, France"
      ],
      "name": "Anahita Rouzé"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine, Catholic University of the Sacred Heart, Rome, Italy",
        "Department of Anesthesia, Emergency and Intensive Care Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy"
      ],
      "name": "Domenico L Grieco"
    },
    {
      "affiliations": [
        "Intensive Care Department, Critical Care Medicine Research Group, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain"
      ],
      "name": "Marta Izura-Gómez"
    },
    {
      "affiliations": [
        "Servei Medicina Intensiva, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain"
      ],
      "name": "Jordi Mancebo"
    },
    {
      "affiliations": [
        "Médecine Intensive-Réanimation, CHU Grenoble Alpes, Grenoble, France",
        "INSERM 1300, HP2, Université Grenoble Alpes, Saint-Martin-d’Hères, France"
      ],
      "name": "Florian Sigaud"
    },
    {
      "affiliations": [
        "Médecine Intensive-Réanimation, CHU Grenoble Alpes, Grenoble, France",
        "INSERM 1300, HP2, Université Grenoble Alpes, Saint-Martin-d’Hères, France"
      ],
      "name": "Nicolas Terzi"
    },
    {
      "affiliations": [
        "Service de réanimation médicale, CHU Nice, Nice, France"
      ],
      "name": "Clément Saccheri"
    },
    {
      "affiliations": [
        "Medical ICU, CHU Nice, Nice, France",
        "UR2CA, Université Côte d’Azur, Nice, France"
      ],
      "name": "Jean Dellamonica"
    },
    {
      "affiliations": [
        "Réanimation polyvalente, Beauvais Hospital, Beauvais, France"
      ],
      "name": "Jack Richecoeur"
    },
    {
      "affiliations": [
        "Unidad de Cuidados Intensivos, Norberto Quirno Center for Medical Education and Clinical Research, Buenos Aires, Argentina"
      ],
      "name": "Mariano Setten"
    },
    {
      "affiliations": [
        "Dipartimento di Scienze Mediche e Chirurgiche, University of Foggia, Foggia, Italy"
      ],
      "name": "Michela Rauseo"
    },
    {
      "affiliations": [
        "Département de Médecine Intensive - Réanimation et Médecine hyperbare, Angers University Hospital, Angers, France",
        "Vent’Lab, University of Angers, Angers, France"
      ],
      "name": "François Beloncle"
    },
    {
      "affiliations": [
        "Service d’Anesthésie-Réanimation Thoraco-Abdominale, CHU de Bordeaux, Pessac, France"
      ],
      "name": "Benjamin Repusseau"
    },
    {
      "affiliations": [
        "Réanimation Polyvalente, Centre Hospitalier de la Cote Basque, Bayonne, France"
      ],
      "name": "Hadrien Rozé"
    },
    {
      "affiliations": [
        "Service de Réanimation (Intensive Care Unit), Robert Picque Military Training Hospital, Villenave-d’Ornon, France"
      ],
      "name": "David Tran-Van"
    },
    {
      "affiliations": [
        "Escuela de Ciencias de la Salud, Departamento de Kinesiología, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile"
      ],
      "name": "Felipe Damiani"
    },
    {
      "affiliations": [
        "Medical Intensive Care Department, CHU Amiens-Picardie, Amiens, France",
        "MP3CV Laboratory, UR 7517, Université de Picardie Jules Verne, Amiens, France"
      ],
      "name": "Michel Slama"
    },
    {
      "affiliations": [
        "Division of Pulmonary, Critical Care, and Sleep Medicine, New York University School of Medicine, New York, New York, USA"
      ],
      "name": "David A Kaufman"
    },
    {
      "affiliations": [
        "Réanimation et Surveillance Continue Adulte, Centre Hospitalier Intercommunal de Créteil, Créteil, France"
      ],
      "name": "Tommaso Maraffi"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Division of Respirology and Critical Care, Department of Medicine, University Health Network, Toronto, Ontario, Canada"
      ],
      "name": "Ewan C Goligher"
    },
    {
      "affiliations": [
        "Service de Médecine Intensive Réanimation, Centre Hospitalier d’Argenteuil, Argenteuil, France"
      ],
      "name": "Gaëtan Plantefève"
    },
    {
      "affiliations": [
        "Department of Intensive Care Medicine, OLVG, Amsterdam, Netherlands"
      ],
      "name": "Rogier Determann"
    },
    {
      "affiliations": [
        "Applied Health Research Centre, Li Ka Shing Knowledge Institute, Unity Health Toronto, Toronto, Ontario, Canada"
      ],
      "name": "Melissa Giamou"
    },
    {
      "affiliations": [
        "Médecine intensive-Réanimation, Hopital Bicetre, Le Kremlin-Bicêtre, France",
        "Inserm U1018, Équipe d’Épidémiologie respiratoire intégrative, Centre de Recherche en Épidémiologie et Santé des Populations, Paris-Saclay University, Villejuif, France"
      ],
      "name": "Tài Pham"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Division of Respirology and Critical Care, Department of Medicine, University Health Network, Toronto, Ontario, Canada"
      ],
      "name": "Lorenzo Del Sorbo"
    },
    {
      "affiliations": [
        "Applied Health Research Centre, Unity Health Toronto, Toronto, Ontario, Canada",
        "St Michael’s Hospital Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada",
        "University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada"
      ],
      "name": "Charles D G Keown-Stoneman"
    },
    {
      "affiliations": [
        "University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada",
        "MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Ontario, Canada"
      ],
      "name": "Rosane Nisenbaum"
    },
    {
      "affiliations": [
        "Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada",
        "Clinical Trials Design and Analysis, The Hospital for Sick Children, Toronto, Ontario, Canada"
      ],
      "name": "Kevin Thorpe"
    },
    {
      "affiliations": [
        "Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada"
      ],
      "name": "Thomas Piraino"
    },
    {
      "affiliations": [
        "Centre of Excellence in Mechanical Ventilation, St Michael’s Hospital Keenan Research Centre for Biomedical Science, Toronto, Ontario, Canada",
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada"
      ],
      "name": "Lu Chen"
    },
    {
      "affiliations": [
        "Clinical Trial Service Unit, University of Oxford Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Peter Jüni"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, Departments of Medicine and Physiology, Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario, Canada",
        "Department of Medicine, Division of Respirology & Critical Care, University Health Network, Toronto, Ontario, Canada"
      ],
      "name": "Niall D Ferguson"
    },
    {
      "affiliations": [
        "Centre of Excellence in Mechanical Ventilation, St Michael’s Hospital Keenan Research Centre for Biomedical Science, Toronto, Ontario, Canada",
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada"
      ],
      "name": "Arthur S Slutsky"
    },
    {
      "affiliations": [
        "Centre of Excellence in Mechanical Ventilation, St Michael’s Hospital Keenan Research Centre for Biomedical Science, Toronto, Ontario, Canada",
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada"
      ],
      "name": "Laurent Brochard"
    },
    {
      "affiliations": [],
      "name": "The CAVIARDS study group"
    }
  ],
  "title": "Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial",
  "uid": "04a288b8-5c2c-59c7-9609-0b6c9b52761a"
}