• Br J Anaesth · Feb 2025

    Randomized Controlled Trial Multicenter Study

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

    • Giacomo Monti, Luca Cabrini, Yuki Kotani, Claudia Brusasco, Assiya Kadralinova, Giuseppe Giardina, Athanasios Chalkias, Cristina Nakhnoukh, Ioannis Pantazopoulos, Federico Mattia Oliva, Federico Dazzi, Agostino Roasio, Martina Baiardo Redaelli, Vincenzo Francesco Tripodi, Giada Cucciolini, Alessandro Belletti, Rosanna Vaschetto, Giulia Maj, Giovanni Borghi, Francesco Savelli, Silvia Boni, Filippo D'Amico, Sarah Cavallero, Rosa Labanca, Moreno Tresoldi, Marilena Marmiere, Matteo Marzaroli, Elena Moizo, Fabrizio Monaco, Pasquale Nardelli, Marina Pieri, Valentina Plumari, Anna Mara Scandroglio, Stefano Turi, Francesco Corradi, Aidos Konkayev, Giovanni Landoni, Rinaldo Bellomo, Alberto Zangrillo, and NAVIGATE Study Group.
    • Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.
    • Br J Anaesth. 2025 Feb 1; 134 (2): 382391382-391.

    BackgroundThe 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.MethodsIn 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.ResultsBetween 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.ConclusionsIn patients with mild acute respiratory failure treated in nonintensive care wards, early NIV reduced the progression to severe acute respiratory failure.Clinical Trial RegistrationNCT01572337.Copyright © 2024 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

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