Your browser doesn't support javascript.
loading
Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan.
Cabrini, Luca; Brusasco, Claudia; Roasio, Agostino; Corradi, Francesco; Nardelli, Pasquale; Filippini, Matteo; Cotticelli, Virginia; Belletti, Alessandro; Ferrera, 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
  • Cabrini L; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Brusasco C; Department of Anesthesia and Intensive Care, EO Ospedali Galliera, Genova, Italy.
  • Roasio A; Department of Anesthesia and Intensive Care, Ospedale Civile di Asti, Asti, Italy.
  • Corradi F; Department of Anesthesia and Intensive Care, EO Ospedali Galliera, Genova, Italy; Università degli Studi di Pisa, Pisa, Italy.
  • Nardelli P; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Filippini M; Department of Anesthesia and Critical Care Medicine, Spedali Civili, Brescia, Italy.
  • Cotticelli V; Department of Anesthesia and Intensive Care, Aurelia Hospital, Roma, Italy.
  • Belletti A; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Ferrera L; Department of Pneumology, Ospedale Villa Scassi ASL 3 Genovese, Genova, Italy.
  • Antonucci E; Department of Emergency-Urgency Medicine, Ospedale Guglielmo da Saliceto, Piacenza, Italy.
  • Baiardo Redaelli M; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Lattuada M; Department of Anesthesia and Intensive Care, EO Ospedali Galliera, Genova, Italy.
  • Colombo S; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Olper L; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Ponzetta G; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Ananiadou S; Department of Anesthesia and Intensive Care, ASST Cremona, Cremona, Italy.
  • Monti G; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Severi L; Department of Anesthesia and Intensive Care, Azienda Ospedaliera San Camillo Forlanini, Roma, Italy.
  • Maj G; Department of Anesthesia and Intensive Care, Sant'Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.
  • Giardina G; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Biondi-Zoccai G; Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; IRCCS NEUROMED, Pozzilli, IS, Italy.
  • Benedetto U; Bristol Heart Institute, University of Bristol, School of Clinical Sciences, Bristol, United Kingdom.
  • Gemma M; Department of Anesthesia and Intensive Care - Ospedale Fatebenefratelli (ASST Fatebenefratelli-Sacco), Milan, Italy.
  • Cavallero SSM; Department of Anesthesia and Intensive Care, Ospedale Civile di Asti, Asti, Italy.
  • Hajjar LA; Department of Cardiopneumology, Heart Institute, Faculty of Medicine, University of Sao Paulo, Hospital Siriolibanes, Sao Paulo, Brazil.
  • Zangrillo A; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University Milan, Italy.
  • Bellomo R; Intensive Care Unit, Austin Hospital, Heidelberg, Melbourne, Australia; Australian and New Zealand Intensive Care Research Center, Monash University, Melbourne, VIC, Australia; School of Medicine, University of Melbourne, Melbourne, VIC, Australia.
  • Landoni G; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University Milan, Italy. Electronic address: landoni.giovanni@hsr.it.
Contemp Clin Trials ; 78: 126-132, 2019 03.
Article in En | MEDLINE | ID: mdl-30739002
OBJECTIVE: 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. DESIGN: Pragmatic, parallel group, randomized, controlled, multicenter trial. SETTING: Non-intensive care wards of tertiary centers. PATIENTS: Non-ICU ward patients with mild to moderate ARF without an established indication for NIV. INTERVENTIONS: Patients will be randomized to receive or not receive NIV in addition to best available care. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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.
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 2_ODS3 / 6_ODS3_enfermedades_notrasmisibles Database: MEDLINE Main subject: Respiratory Insufficiency / Noninvasive Ventilation Type of study: Clinical_trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: Contemp Clin Trials Year: 2019 Document type: Article

Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 / 2_ODS3 / 6_ODS3_enfermedades_notrasmisibles Database: MEDLINE Main subject: Respiratory Insufficiency / Noninvasive Ventilation Type of study: Clinical_trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: Contemp Clin Trials Year: 2019 Document type: Article