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. 2019 Mar:78:126-132.
doi: 10.1016/j.cct.2019.02.001. Epub 2019 Feb 7.

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

Luca Cabrini  1 , Claudia Brusasco  2 , Agostino Roasio  3 , Francesco Corradi  4 , Pasquale Nardelli  1 , Matteo Filippini  5 , Virginia Cotticelli  6 , Alessandro Belletti  1 , Lorenzo Ferrera  7 , Elio Antonucci  8 , Martina Baiardo Redaelli  1 , Marco Lattuada  2 , Sergio Colombo  1 , Luigi Olper  1 , Giuseppe Ponzetta  1 , Sofia Ananiadou  9 , Giacomo Monti  1 , Luca Severi  10 , Giulia Maj  11 , Giuseppe Giardina  1 , Giuseppe Biondi-Zoccai  12 , Umberto Benedetto  13 , Marco Gemma  14 , Sarah Sophia Michelle Cavallero  3 , Ludhmila Abrahao Hajjar  15 , Alberto Zangrillo  16 , Rinaldo Bellomo  17 , Giovanni Landoni  18
Affiliations

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

Luca Cabrini et al. Contemp Clin Trials. 2019 Mar.

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.

Trial registration: ClinicalTrials.gov NCT01572337.

Keywords: ARF; Acute respiratory failure; NIV; Non-invasive ventilation.

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