Early Acute Respiratory FailurePhase 4NAVIGATENCT01572337
Early Non-invasive Ventilation Outside the Intensive Care Unit
A Phase 4 study testing Non-invasive ventilation in people with Early Acute Respiratory Failure, run by Università Vita-Salute San Raffaele at 14 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Early Acute Respiratory Failure
- What is being tested?
- Non-invasive ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Apr 2012to 18 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Italy12 sites
Ospedale Cesare Arrigo
Alessandria, Piedmont, 15121
Ospedale Civile di Asti
Asti
Spedali Civili
Brescia
Asl 3 Genovese
Genova
Ospedali Galliera
Genova
Ospedale San Raffaele di Milano
Milan, MI, 20132
Ospedale di Novara
Novara, Piedmont
AOU Pisana
Pisa
Grande Ospedale Metropolitano
Reggio Calabria
Aurelia Hospital
Roma
Policlinico A. Gemelli
Roma
Azienda Ospedaliera San Giovanni Battista Molinette
Torino
About this study
Official title: Reducing the Need for Intensive Care Unit in Hospitalized Patients With Early Respiratory Failure Using the Non-invasive Ventilation Technique. A Multicentre Randomized Study.
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
- Being tested
- Non-invasive ventilation, Standard care
- Keywords
- NIV, acute respiratory failure, hypoxia, hypercapnia, non-invasive ventilation, hospital ward
- Medical subject headings
- Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationProcedure or surgery
Also called Noninvasive ventilation, NIV
Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure
Standard careOther
| Study group | Role | What they receive |
|---|---|---|
| NIV | Experimental | Non-invasive ventilation Receives: Procedure: Non-invasive ventilation |
| Best available treatment | Other | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startApr 2012
- Primary completion17 Aug 2023
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572337
- Sponsor's protocol ID
- VP/96/ER/mm
- Acronym
- NAVIGATE
- Status last verified
- Aug 2025
- First submitted
- 16 Mar 2012
- Last updated
- 7 Aug 2025
- Results posted
- No
Publications
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.
PubMed 24444661Cabrini 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.
PubMed 24364004Monti 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.
PubMed 39753402Cabrini 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.
PubMed 30739002
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Need for Intensive Care Unit in Hospitalized Patients With Early Respiratory Failure Using the Non-invasive Ventilation Technique. A Multicentre Randomized Study.
- ClinicalTrials.gov ID
- NCT01572337
- Acronym / sponsor ID
- NAVIGATE / VP/96/ER/mm
- Conditions
- Early Acute Respiratory Failure
- Keywords
- NIV, acute respiratory failure, hypoxia, hypercapnia, non-invasive ventilation, hospital ward
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV | Experimental | Procedure: Non-invasive ventilationNon-invasive ventilation |
| Best available treatment | Other | Other: Standard care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilationAlso: Noninvasive ventilation, NIVEarly non-invasive ventilation will be given to patients at an early stage of acute respiratory failure | Procedure or surgery | NIV |
| Standard care | Other | Best available treatment |
Primary outcome
Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 24444661Cabrini 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.
- Background: PubMed 24364004Cabrini 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.
- Results publication: PubMed 39753402Monti 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.
- Derived from this study: PubMed 30739002Cabrini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-invasive ventilation in people with Early Acute Respiratory Failure, run by Università Vita-Salute San Raffaele at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, Greece, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure (time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572337, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.