ClinicalTrials.gg
RecruitingNCT01571986Improving NIVUpdated Jul 1, 2025

Improving Non-invasive Ventilation

An observational study in Acute Respiratory Failure, sponsored by Università Vita-Salute San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Università Vita-Salute San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Feb 2012; still recruiting 14 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
750
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Failure

Keywords

  • NIV
  • acute respiratory failure
  • hypoxia
  • hypercapnia
  • non-invasive ventilation
  • hospital ward
03

In context

Hypoxia

1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.

This study's planned enrollment of 750 is above the median of 79 across 277 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Università Vita-Salute San Raffaele is the lead sponsor of 85 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • treatment with non-invasive ventilation

Exclusion criteria

Exclusion Criteria:

  • refusal of
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
750 participants (estimated)

Groups and cohorts

  • NIV

    All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data

    Procedure: Non-invasive ventilation

Interventions

  • ProcedureNon-invasive ventilation

    Non-invasive ventilation

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 24444661 ↗
  • 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. PubMed 24364004 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01571986
Lead sponsor
Università Vita-Salute San Raffaele
Responsible party
Giovanni Landoni (Principal Investigator, Università Vita-Salute San Raffaele) — Principal investigator
First posted
Apr 5, 2012
Start date
Feb 2012
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Jul 1, 2025

Study contacts

Luca Cabrini, MD
Contact
cabrini.luca@hsr.it

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion