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Title: Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan.
Austin Authors: Cabrini, Luca;Brusasco, Claudia;Roasio, Agostino;Corradi, Francesco;Nardelli, Pasquale;Filippini, Matteo;Cotticelli, Virginia;Belletti, Alessandro;Ferrara, Lorenzo;Antonucci, Elio;Baiardo Redaelli, Martina;Lattuada, Marco;Colombo, Sergio;Olper, Luigi;Ponzetta, Giuseppe;Ananiadou, Sofia;Monti, Giacomo;Severi, Luca;Maj, Giulia;Giardina, Giuseppe;Biondi-Zoccai, Giuseppe;Benedetto, Umberto;Gemma, Marco;Cavallero, Sarah Sophia Michelle;Hajjar, Ludhmila Abrahao;Zangrillo, Alberto;Bellomo, Rinaldo ;Landoni, Giovanni
Affiliation: Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy
Department of Anesthesia and Intensive Care, EO Ospedali Galliera, Genova, Italy
Department of Anesthesia and Intensive Care, Ospedale Civile di Asti, Asti, Italy
Università degli Studi di Pisa, Pisa, Italy
Department of Anesthesia and Critical Care Medicine, Spedali Civili, Brescia, Italy
Department of Anesthesia and Intensive Care, Aurelia Hospital, Roma, Italy
Department of Pneumology, Ospedale Villa Scassi ASL 3 Genovese, Genova, Italy
Department of Anesthesia and Intensive Care, Azienda Ospedaliera San Camillo Forlanini, Roma, Italy
Bristol Heart Institute, University of Bristol, School of Clinical Sciences, Bristol, United Kingdom
Department of Anesthesia and Intensive Care, Ospedale Civile di Asti, Asti, Italy
Department of Cardiopneumology, Heart Institute, Faculty of Medicine, University of Sao Paulo, Hospital Siriolibanes, Sao Paulo, Brazil
IRCCS NEUROMED, Pozzilli, IS, Italy
Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy
Australian and New Zealand Intensive Care Research Center, Monash University, Melbourne, VIC, Australia
Department of Intensive Care, Austin Health, Heidelberg, Victoria, Australia
Vita-Salute San Raffaele University Milan, Italy
Issue Date: Mar-2019 2019-02-07
Publication information: Contemporary clinical trials 2019; 78: 126-132
Abstract: Few randomized trials have evaluated the use of non-invasive ventilation (NIV) for early acute respiratory failure (ARF) in non-intensive care unit (ICU) wards. The aim of this study is to test the hypothesis that early NIV for mild-moderate ARF in non-ICU wards can prevent development of severe ARF. Pragmatic, parallel group, randomized, controlled, multicenter trial. Non-intensive care wards of tertiary centers. Non-ICU ward patients with mild to moderate ARF without an established indication for NIV. Patients will be randomized to receive or not receive NIV in addition to best available care. We will enroll 520 patients, 260 in each group. The primary endpoint of the study will be the development of severe ARF. Secondary endpoints will be 28-day mortality, length of hospital stay, safety of NIV in non-ICU environments, and a composite endpoint of all in-hospital respiratory complications. This trial will help determine whether the early use of NIV in non-ICU wards can prevent progression from mild-moderate ARF to severe ARF.
DOI: 10.1016/j.cct.2019.02.001
ORCID: 0000-0002-1650-8939
PubMed URL: 30739002
Type: Journal Article
Subjects: ARF
Acute respiratory failure
Non-invasive ventilation
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