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 Giardina; Giuseppe Biondi-Zoccai; Umberto Benedetto; Marco Gemma; Sarah Sophia Michelle Cavallero; Ludhmila Abrahao Hajjar; Alberto Zangrillo; Rinaldo Bellomo; Giovanni Landoni

doi:10.1016/j.cct.2019.02.001

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

Bristol Medical School (THS)

Research output: Contribution to journal › Article (Academic Journal) › peer-review

3 Citations (Scopus)

180 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 language	English
Pages (from-to)	126-132
Number of pages	7
Journal	Contemporary Clinical Trials
Volume	78
Early online date	7 Feb 2019
DOIs	https://doi.org/10.1016/j.cct.2019.02.001
Publication status	Published - Mar 2019

Keywords

Acute respiratory failure
ARF
NIV
Non-invasive ventilation

Access to Document

10.1016/j.cct.2019.02.001

Full-text PDF (accepted author manuscript)
This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Elsevier at https://www.sciencedirect.com/science/article/pii/S1551714418306372?via%3Dihub. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 2.4 MBLicence: CC BY-NC-ND

Handle.net

Persistent link

Cite this

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

@article{5db411ae340f4012bd4d900aa9cf9cdf,

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

abstract = "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.",

keywords = "Acute respiratory failure, ARF, NIV, Non-invasive ventilation",

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

year = "2019",

month = mar,

doi = "10.1016/j.cct.2019.02.001",

language = "English",

volume = "78",

pages = "126--132",

journal = "Contemporary Clinical Trials",

issn = "1551-7144",

publisher = "Elsevier Inc.",

}

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, SSM, Hajjar, LA, 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

Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE) : A multicenter randomized controlled study. Protocol and statistical analysis plan. / Cabrini, Luca; Brusasco, Claudia; Roasio, Agostino et al.

In: Contemporary Clinical Trials, Vol. 78, 03.2019, p. 126-132.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE)

T2 - A multicenter randomized controlled study. Protocol and statistical analysis plan

AU - Cabrini, Luca

AU - Brusasco, Claudia

AU - Roasio, Agostino

AU - Corradi, Francesco

AU - Nardelli, Pasquale

AU - Filippini, Matteo

AU - Cotticelli, Virginia

AU - Belletti, Alessandro

AU - Ferrara, Lorenzo

AU - Antonucci, Elio

AU - Baiardo Redaelli, Martina

AU - Lattuada, Marco

AU - Colombo, Sergio

AU - Olper, Luigi

AU - Ponzetta, Giuseppe

AU - Ananiadou, Sofia

AU - Monti, Giacomo

AU - Severi, Luca

AU - Maj, Giulia

AU - Giardina, Giuseppe

AU - Biondi-Zoccai, Giuseppe

AU - Benedetto, Umberto

AU - Gemma, Marco

AU - Cavallero, Sarah Sophia Michelle

AU - Hajjar, Ludhmila Abrahao

AU - Zangrillo, Alberto

AU - Bellomo, Rinaldo

AU - Landoni, Giovanni

PY - 2019/3

Y1 - 2019/3

N2 - 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.

AB - 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.

KW - Acute respiratory failure

KW - ARF

KW - NIV

KW - Non-invasive ventilation

UR - http://www.scopus.com/inward/record.url?scp=85061427183&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2019.02.001

DO - 10.1016/j.cct.2019.02.001

M3 - Article (Academic Journal)

C2 - 30739002

AN - SCOPUS:85061427183

VL - 78

SP - 126

EP - 132

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

ER -

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

Abstract

Keywords

Access to Document

Handle.net

Other files and links

Fingerprint

Cite this