A Phase 4 interventional study of Non-invasive ventilation and Standard care in Early Acute Respiratory Failure, sponsored by Università Vita-Salute San Raffaele. Completed at 14 sites in 3 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Università Vita-Salute San Raffaele · Phase 4, Interventional, and Prevention
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's enrollment of 520 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →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.
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.
Exclusion Criteria:
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-invasive ventilation
Procedure: Non-invasive ventilation
Other: Standard care
Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure
Also known as: Noninvasive ventilation, NIV
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
Ran from Apr 2012 to primary completion in Aug 2023, 136 months.
Of 17 phase 4 interventional studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's 136 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Università Vita-Salute San Raffaele