Contemporary clinical trials · 2019
Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
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.
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.
Предметные рубрики MeSH
AdolescentAdultAgedFemaleHumansMaleMiddle AgedYoung AdultAcute DiseaseAge FactorsComorbidityDisease ProgressionHospital MortalityLength of StayNoninvasive VentilationResearch DesignRespiratory InsufficiencySex FactorsTertiary Care CentersMulticenter Studies as TopicPragmatic Clinical Trials as Topic