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

Luca Cabrini, Claudia Brusasco, Agostino Roasio, Francesco Corradi, Pasquale Nardelli, Matteo Filippini, Virginia Cotticelli, Alessandro Belletti, Lorenzo Ferrara, Elio Antonucci, Martina Baiardo Redaelli, Marco Lattuada, Sergio Colombo, Luigi Olper, Giuseppe Ponzetta, Sofia Ananiadou, Giacomo Monti, Luca Severi, Giulia Maj, Giuseppe GiardinaGiuseppe Biondi-Zoccai, Umberto Benedetto, Marco Gemma, Sarah Sophia Michelle Cavallero, Ludhmila Abrahao Hajjar, Alberto Zangrillo, Rinaldo Bellomo, Giovanni Landoni*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)

2 Citations (Scopus)
84 Downloads (Pure)

Abstract

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.
Original languageEnglish
Pages (from-to)126-132
Number of pages7
JournalContemporary Clinical Trials
Volume78
Early online date7 Feb 2019
DOIs
Publication statusPublished - Mar 2019

Keywords

  • Acute respiratory failure
  • ARF
  • NIV
  • Non-invasive ventilation

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    Cabrini, L., Brusasco, C., Roasio, A., Corradi, F., Nardelli, P., Filippini, M., Cotticelli, V., Belletti, A., Ferrara, L., Antonucci, E., Baiardo Redaelli, M., Lattuada, M., Colombo, S., Olper, L., Ponzetta, G., Ananiadou, S., Monti, G., Severi, L., Maj, G., ... Landoni, G. (2019). Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan. Contemporary Clinical Trials, 78, 126-132. https://doi.org/10.1016/j.cct.2019.02.001