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A large multicentre, randomized, controlled trial to demonstrate that non invasive ventilation given at an early stage of acute respiratory failure (ARF) outside the intensive care unit (ICU) can prevent the deterioration of ARF and the need for ICU when compared to the best available treatment usually performed in the non-ICU wards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIV | Experimental | Non-invasive ventilation |
|
| Best available treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive ventilation | Procedure | Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Thessaly | Larissa | Greece | ||||
| Ospedale San Raffaele di Milano |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24444661 | Background | Cabrini L, Nobile L, Plumari VP, Landoni G, Borghi G, Mucchetti M, Zangrillo A. Intraoperative prophylactic and therapeutic non-invasive ventilation: a systematic review. Br J Anaesth. 2014 Apr;112(4):638-47. doi: 10.1093/bja/aet465. Epub 2014 Jan 19. | |
| 24364004 | Background | Cabrini L, Plumari VP, Nobile L, Olper L, Pasin L, Bocchino S, Landoni G, Beretta L, Zangrillo A. Non-invasive ventilation in cardiac surgery: a concise review. Heart Lung Vessel. 2013;5(3):137-41. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Standard care | Other |
|
| Milan |
| MI |
| 20132 |
| Italy |
| Ospedale Cesare Arrigo | Alessandria | Piedmont | 15121 | Italy |
| Ospedale di Novara | Novara | Piedmont | Italy |
| Ospedale Civile di Asti | Asti | Italy |
| Spedali Civili | Brescia | Italy |
| Asl 3 Genovese | Genova | Italy |
| Ospedali Galliera | Genova | Italy |
| AOU Pisana | Pisa | Italy |
| Grande Ospedale Metropolitano | Reggio Calabria | Italy |
| Aurelia Hospital | Roma | Italy |
| Policlinico A. Gemelli | Roma | Italy |
| Azienda Ospedaliera San Giovanni Battista Molinette | Torino | Italy |
| Astana Medical University | Kazakhstan | Kazakhstan |
| 39753402 | Result | Monti G, Cabrini L, Kotani Y, Brusasco C, Kadralinova A, Giardina G, Chalkias A, Nakhnoukh C, Pantazopoulos I, Oliva FM, Dazzi F, Roasio A, Baiardo Redaelli M, Tripodi VF, Cucciolini G, Belletti A, Vaschetto R, Maj G, Borghi G, Savelli F, Boni S, D'Amico F, Cavallero S, Labanca R, Tresoldi M, Marmiere M, Marzaroli M, Moizo E, Monaco F, Nardelli P, Pieri M, Plumari V, Scandroglio AM, Turi S, Corradi F, Konkayev A, Landoni G, Bellomo R, Zangrillo A; NAVIGATE Study Group. Early noninvasive ventilation in general wards for acute respiratory failure: an international, multicentre, open-label, randomised trial. Br J Anaesth. 2025 Feb;134(2):382-391. doi: 10.1016/j.bja.2024.11.023. Epub 2025 Jan 2. |
| 30739002 | Derived | Cabrini L, Brusasco C, Roasio A, Corradi F, Nardelli P, Filippini M, Cotticelli V, Belletti A, Ferrera 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. Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan. Contemp Clin Trials. 2019 Mar;78:126-132. doi: 10.1016/j.cct.2019.02.001. Epub 2019 Feb 7. |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |