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

2019-03

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

ARF

Acute respiratory failure

NIV

Non-invasive ventilation

Journal Article

0000-0002-1650-8939

10.1016/j.cct.2019.02.001

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.

link

Contemporary clinical trials 2019; 78: 126-132

Contemporary clinical trials