Early Non-invasive Ventilation Outside the Intensive Care Unit

NCT01572337 | Completed Phase 4

• 1 other identifier: VP/96/ER/mm
• Study Type: interventional
• Target: 520
• Locations: 3 countries
• Sites: 14

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

Keywords

NIV; acute respiratory failure; hypoxia; hypercapnia; non-invasive ventilation; hospital ward

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NIV

EXPERIMENTAL

Non-invasive ventilation

Procedure: Non-invasive ventilation

Best available treatment

OTHER

Other: Standard care

Interventions

Non-invasive ventilation PROCEDURE

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

Also known as: Noninvasive ventilation, NIV

NIV

Standard care OTHER

Best available treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (14)

University of Thessaly

Larissa, Greece

Location

Ospedale San Raffaele di Milano

Milan, MI, 20132, Italy

Location

Ospedale Cesare Arrigo

Alessandria, Piedmont, 15121, Italy

Location

Ospedale di Novara

Novara, Piedmont, Italy

Location

Ospedale Civile di Asti

Asti, Italy

Location

Spedali Civili

Brescia, Italy

Location

Asl 3 Genovese

Genova, Italy

Location

Ospedali Galliera

Genova, Italy

Location

AOU Pisana

Pisa, Italy

Location

Grande Ospedale Metropolitano

Reggio Calabria, Italy

Location

Aurelia Hospital

Roma, Italy

Location

Policlinico A. Gemelli

Roma, Italy

Location

Azienda Ospedaliera San Giovanni Battista Molinette

Torino, Italy

Location

Astana Medical University

Kazakhstan, Kazakhstan

Location

Related Publications (4)

• 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.

  PMID: 24444661 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.

  PMID: 24364004 BACKGROUND

• 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.

  PMID: 39753402 RESULT

• 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.

  PMID: 30739002 DERIVED

MeSH Terms

Conditions

Hypoxia; Hypercapnia

Interventions

Noninvasive Ventilation; Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Department of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: April 6, 2012
• Study Start: April 1, 2012
• Primary Completion: August 17, 2023
• Study Completion: July 18, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

GR (1); IT (12); KA (1)