Early Non-invasive Ventilation Outside the Intensive Care Unit

NCT ID: NCT01572337

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2024-07-18

Brief Summary

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.

Conditions

Early Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NIV

Non-invasive ventilation

Group Type: EXPERIMENTAL

Non-invasive ventilation

Intervention Type: PROCEDURE

Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure

Best available treatment

Group Type: OTHER

Standard care

Intervention Type: OTHER

Interventions

Non-invasive ventilation

Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure

Intervention Type: PROCEDURE

Standard care

Intervention Type: OTHER

Other Intervention Names

Noninvasive ventilation; NIV

Eligibility Criteria

Inclusion Criteria

• Informed consent
• Age >= 18 years
• Admission in a non-intensive-care department
• Radiological evidence of new pulmonary consolidation or atelectasis
• Peripheral Oxygen saturation less than 92% while breathing room air or PaO2/FiO2 ratio less than 300 at blood gas analysis
• Decompensated hypercapnia (pCO2 > 45 mmHg and pH < 7.35)
• Clinical signs of respiratory distress (dyspnoea, utilization of accessory respiratory muscles, paradox movements of thoraco-abdominal wall) in air.

Exclusion Criteria

• Respiratory failure due to chronic obstructive pulmonary disease exacerbation, defined as PaCO2 > 45 and pH < 7.35 (in these patients NIV is considered to be the standard/first line treatment and we do not want to deny these patients the opportunity to receive this treatment because of randomization)
• Severe, hypercapnic ARF defined as PaCO2 > 45 and pH < 7.30
• Severe, hypoxic ARF defined as PaO2/FiO2 < 200
• Need for immediate mechanical ventilation or ICU as judged by the ICU physician in charge
• Extremely poor short term prognosis (imminent death with decision for palliative treatment only)
• Invasive or non-invasive mechanical ventilation during the same hospitalization due to respiratory failure.
• Clear contraindication to NIV treatment: respiratory arrest, failure to correct positioning of a face mask, hemodynamic instability due to hypotensive shock, ongoing myocardial ischemia, arrhythmia, massive bleeding from upper gastrointestinal tract, patient uncooperative and upset, inability to protect airways, alterations of deglutition, inability to clear secretion also with external aspiration, multiple organs dysfunction, recent surgery of airways or upper gastrointestinal tract, not-drained pneumothorax, bowel obstruction, active vomit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università Vita-Salute San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Landoni

Head of Research, Department of Anesthesiology and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Thessaly

Larissa, , Greece

Ospedale San Raffaele di Milano

Milan, MI, Italy

Ospedale Cesare Arrigo

Alessandria, Piedmont, 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

Countries

Greece; Italy; Kazakhstan

References

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.

Reference Type: BACKGROUND

PMID: 24364004 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24444661 (View on PubMed)

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.

Reference Type: RESULT

PMID: 39753402 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30739002 (View on PubMed)

Other Identifiers

VP/96/ER/mm

Identifier Type: -

Identifier Source: org_study_id