Acute Respiratory FailureImproving NIVNCT01571986
Improving Non-invasive Ventilation
An observational study of Acute Respiratory Failure, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
A single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Non-invasive ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data
Who may be able to join
- treatment with non-invasive ventilation
- informed consent
Who cannot join
- refusal of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luca Cabrini, MD contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele di Milano
Milan, 20132
Luca Cabrini, cabrini.luca@hsr.it
About this study
Official title: Improving Non Invasive Ventilation
A single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.
- Conditions
- Acute Respiratory Failure
- Being tested
- Non-invasive ventilation
- 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
Non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| NIV | All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data Receives: Procedure: Non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients requiring NIV in a large university hospital. Incidence of NIV failure (including patient compliance) and NIV related complications. Imaging (chest ultrasound) in a subgroup of patients before and after receiving NIV.
Measured: Outcome measures will be assessed every day and participants will be followed for the duration of hospital stay, an expected average of 1 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
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
- NCT01571986
- Sponsor's protocol ID
- VP/50/ER/mm
- Acronym
- Improving NIV
- Status last verified
- Jun 2025
- First submitted
- 16 Mar 2012
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 24364004
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Non Invasive Ventilation
- ClinicalTrials.gov ID
- NCT01571986
- Acronym / sponsor ID
- Improving NIV / VP/50/ER/mm
- Conditions
- Acute Respiratory Failure
- Keywords
- NIV, acute respiratory failure, hypoxia, hypercapnia, non-invasive ventilation, hospital ward
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 5 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 single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIV | – | Procedure: Non-invasive ventilationAll patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data
Key inclusion criteria (2 listed)
- treatment with non-invasive ventilation
- informed consent
Key exclusion criteria (1 listed)
- refusal of informed consent
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 ventilationNon-invasive ventilation | Procedure or surgery | NIV |
Primary outcome
Number of patients requiring NIV in a large university hospital. Incidence of NIV failure (including patient compliance) and NIV related complications. Imaging (chest ultrasound) in a subgroup of patients before and after receiving NIV.
Time frame: Outcome measures will be assessed every day and participants will be followed for the duration of hospital stay, an expected average of 1 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 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.
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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.
Luca Cabrini, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Cabrini, MD (cabrini.luca@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients requiring NIV in a large university hospital. Incidence of NIV failure (including patient compliance) and NIV related complications. Imaging (chest ultrasound) in a subgroup of patients before and after receiving NIV. (time frame: Outcome measures will be assessed every day and participants will be followed for the duration of hospital stay, an expected average of 1 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 NCT01571986, which also lists 2 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 1 Jul 2025.