Early noninvasive ventilation in general wards for acute respiratory failure: an international, multicentre, open-label, randomised trial


Monti G. Cabrini L. Kotani Y. Brusasco C. Kadralinova A. Giardina G. Chalkias A. Nakhnoukh C. Pantazopoulos I. Oliva F.M. Dazzi F. Roasio A. Baiardo Redaelli M. Tripodi V.F. Cucciolini G. Belletti A. Vaschetto R. Maj G. Borghi G. Savelli F. Boni S. DAmico F. Cavallero S. Labanca R. Tresoldi M. Marmiere M. Marzaroli M. Moizo E. Monaco F. Nardelli P. Pieri M. Plumari V. Scandroglio A.M. Turi S. Corradi F. Konkayev A. Landoni G. Bellomo R. Zangrillo A.
February 2025Elsevier Ltd

British Journal of Anaesthesia
2025#134Issue 2382 - 391 pp.

Background: The impact of noninvasive ventilation (NIV) managed outside the intensive care unit in patients with early acute respiratory failure remains unclear. We aimed to determine whether adding early NIV prevents the progression to severe respiratory failure. Methods: In this multinational, randomised, open-label controlled trial, adults with mild acute respiratory failure (arterial oxygen partial pressure/fraction of inspiratory oxygen [PaO2/FiO2] ratio ≥200) were enrolled across 11 hospitals in Italy, Greece, and Kazakhstan. Patients were randomised to receive early NIV or usual care. Patients in the early NIV group received 2-h cycles of NIV applied every 8 h for up to 12 days. The primary outcome was the progression to severe acute respiratory failure, defined by severe hypoxaemia, severe respiratory distress, or hypercapnic acidaemia during hospitalisation. Results: Between May 6, 2012, and July 18, 2023, we randomised 524 patients (44.8% female; median age 73 yr, interquartile range [IQR] 63–83 yr). One patient withdrew consent. Progression to severe acute respiratory failure occurred in 49/265 (18.5%) patients randomised to early NIV, compared with 73/258 (28.3%) patients receiving usual care (relative risk 0.65, 95% confidence interval 0.48–0.90, P=0.0080). Median length of hospital stay was 10 (IQR 6–16) days in the early NIV group and 9 (IQR 5–16) days in the usual care group (P=0.30). Respiratory complications, 28-day mortality, and adverse events were not different between early NIV and usual care. Conclusions: In patients with mild acute respiratory failure treated in nonintensive care wards, early NIV reduced the progression to severe acute respiratory failure. Clinical trial registration: NCT01572337.

continuous positive airway pressure , intensive care unit , intubation , noninvasive ventilation , respiratory insufficiency

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Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy
School of Medicine, Vita-Salute San Raffaele University, Milan, Italy
Department of Biotechnologies and Life Science, University of Insubria, Varese, Italy
Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi di Varese, Varese, Italy
Department of Intensive Care Medicine, Kameda Medical Center, Kamogawa, Japan
Anaesthesia and Intensive Care Unit, Galliera Hospital, Genoa, Italy
Department of Anesthesiology and Intensive Care, Astana Medical University, Astana, Kazakhstan
Department of Anesthesiology and Intensive Care, National Scientific Center of Traumatology and Orthopedics named after N. Batpenov, Astana, Kazakhstan
Institute for Translational Medicine and Therapeutics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, United States
OUTCOMES RESEARCH Consortium®, Houston, TX, United States
Department of Respiratory Medicine, Faculty of Medicine, University of Thessaly, Larisa, Greece
Department of Emergency Medicine, Faculty of Medicine, University of Thessaly, Larisa, Greece
Department of Surgical, Medical, Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy
Department of Anesthesia and Intensive Care Medicine, Cardinal Massaia Hospital, Asti, Italy
Cardiac Anesthesia and Intensive Care, Cardio-Thoraco-Vascular Department, ‘Bianchi-Melacrino-Morelli’ Hospital, Reggio Calabria, Italy
Anesthesia and Intensive Care, Surgery Department, ‘Gaetano Martino’ University Hospital, Messina, Italy
Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale, Novara, Italy
Department of Anesthesia and Intensive Care, SantAntonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy
First Aid and Emergency Medicine, Ospedale ‘degli Infermi’ Di Faenza, Faenza, Italy
Department of Infectious Disease, Galliera Hospital, Genoa, Italy
Department of Orthopedic Surgery, Cardinal Massaia Hospital, Asti, Italy
Department of Critical Care, The University of Melbourne, Melbourne, VIC, Australia
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia

Department of Anesthesia and Intensive Care
School of Medicine
Department of Biotechnologies and Life Science
Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi di Varese
Department of Intensive Care Medicine
Anaesthesia and Intensive Care Unit
Department of Anesthesiology and Intensive Care
Department of Anesthesiology and Intensive Care
Institute for Translational Medicine and Therapeutics
OUTCOMES RESEARCH Consortium®
Department of Respiratory Medicine
Department of Emergency Medicine
Department of Surgical
Department of Anesthesia and Intensive Care Medicine
Cardiac Anesthesia and Intensive Care
Anesthesia and Intensive Care
Dipartimento di Medicina Traslazionale
Department of Anesthesia and Intensive Care
First Aid and Emergency Medicine
Department of Infectious Disease
Department of Orthopedic Surgery
Department of Critical Care
Australian and New Zealand Intensive Care Research Centre

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