Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan

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...

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Bibliographic Details
Published in:Contemporary clinical trials 2019-03, Vol.78, p.126-132
Main Authors: 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
Format: Article
Language:English
Subjects:
Acute Disease
Acute respiratory failure
Adolescent
Adult
Age Factors
Aged
ARF
Comorbidity
Disease Progression
Female
Hospital Mortality
Humans
Length of Stay
Male
Middle Aged
Multicenter Studies as Topic
NIV
Non-invasive ventilation
Noninvasive Ventilation - methods
Pragmatic Clinical Trials as Topic
Research Design
Respiratory Insufficiency - therapy
Sex Factors
Tertiary Care Centers
Young Adult
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Summary: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.
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2019.02.001