Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan
| Autor: | Elio Antonucci, Sergio Colombo, Giulia Maj, Francesco Corradi, Rinaldo Bellomo, Giuseppe Ponzetta, Luigi Olper, Marco Gemma, Claudia Brusasco, Giuseppe Biondi-Zoccai, Sofia Ananiadou, Lorenzo Ferrara, Alessandro Belletti, Agostino Roasio, Luca Cabrini, Matteo Filippini, Pasquale Nardelli, Luca Severi, Ludhmila Abrahão Hajjar, Giuseppe Giardina, Marco Lattuada, Alberto Zangrillo, Sarah Sophia Michelle Cavallero, Giacomo Monti, Martina Baiardo Redaelli, Umberto Benedetto, Virginia Cotticelli, Giovanni Landoni |
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| Přispěvatelé: | Cabrini, Luca, Brusasco, Claudia, Roasio, Agostino, Corradi, Francesco, Nardelli, Pasquale, Filippini, Matteo, Cotticelli, Virginia, Belletti, Alessandro, Ferrara, Lorenzo, Antonucci, Elio, Redaelli, Martina Baiardo, Lattuada, Marco, Colombo, Sergio, Olper, Luigi, Ponzetta, Giuseppe, Ananiadou, Sofia, Monti, Giacomo, Severi, Luca, Maj, Giulia, Giardina, Giuseppe, Zoccai, Giuseppe Biondi, Benedetto, Umberto, Gemma, Marco, Cavallero, Sarah Sophia Michelle, Hajjar, Ludhmila Abrahao, Zangrillo, Alberto, Bellomo, Rinaldo, Landoni, Giovanni |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Research design
Adult Male medicine.medical_specialty Adolescent Psychological intervention Comorbidity Acute respiratory failure law.invention Tertiary Care Centers 03 medical and health sciences Young Adult 0302 clinical medicine Sex Factors Randomized controlled trial law Multicenter trial Clinical endpoint Medicine Humans Pharmacology (medical) 030212 general & internal medicine Hospital Mortality Young adult Aged ARF NIV Non-invasive ventilation 030505 public health Noninvasive Ventilation business.industry Age Factors General Medicine Length of Stay Middle Aged medicine.disease Respiratory failure Research Design Emergency medicine Acute Disease Disease Progression Female 0305 other medical science business Respiratory Insufficiency |
| Zdroj: | 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, Giardina, G, Biondi-Zoccai, G, Benedetto, U, Gemma, M, Cavallero, S S M, Hajjar, L A, Zangrillo, A, Bellomo, R & 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, vol. 78, pp. 126-132 . https://doi.org/10.1016/j.cct.2019.02.001 |
| Popis: | ObjectiveFew 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.DesignPragmatic, parallel group, randomized, controlled, multicenter trial.SettingNon-intensive care wards of tertiary centers.PatientsNon-ICU ward patients with mild to moderate ARF without an established indication for NIV.InterventionsPatients will be randomized to receive or not receive NIV in addition to best available care.Measurements and main resultsWe 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.ConclusionsThis trial will help determine whether the early use of NIV in non-ICU wards can prevent progression from mild-moderate ARF to severe ARF. |
| Databáze: | OpenAIRE |
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