Comparing Non-invasive Ventilation and High Flow Oxygen for Pneumonia-related Breathing Issues
Official title: Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure
Run by Niguarda Hospital · NCT03758508 · Data updated 2026-11-12
This study is testing if using both Non-Invasive Ventilation and High Flow Oxygen together helps people with pneumonia-related breathing problems breathe better than just using High Flow Oxygen alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | November 1, 2017 |
| Main results expected | November 1, 2019 |
| Study ends | December 1, 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT03758508 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with pneumonia who are experiencing acute hypoxemic respiratory failure.
✕Probably not a fit
Patients under 18 years old or those with hypercapnic respiratory failure or other causes of hypoxemic respiratory failure may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the effectiveness of alternating Non-Invasive Ventilation (NIV) and High Flow Oxygen (HFO) against HFO alone in patients suffering from pneumonia-associated acute hypoxemic respiratory failure. It seeks to evaluate whether the combination of these two methods improves gas exchange and overall prognosis compared to using HFO by itself. Participants will be monitored for their respiratory function and clinical outcomes to determine the best approach for treatment in this specific patient population.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with pneumonia-related respiratory failure, enhancing their recovery and quality of life.
How similar studies have gone: Previous studies have explored the use of NIV and HFO in respiratory failure, but this specific comparison in pneumonia cases is less established, making this approach somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following: * Clinical criteria: fever, cough, purulent sputum, pulmonary examination positive for signs consistent with pneumonia * Laboratory criteria: leukocytosis (White blood cells \>10000/mcL) or leukopenia (White blood cells \< 4000/mcL), rise of the inflammatory markers * Radiologic criteria: consolidations at Chest X-ray or CT scan * Hypoxemic respiratory failure, based on all the following criteria * PaO2/FiO2 \< 300 after at least 15 minutes conventional oxygen therapy with a FiO2 ≥ 50% * Respiratory Rate (RR) ≥ 25/min or need for use of accessory muscles * Informed consent to study participation Exclusion Criteria: * Age \< 18 years * Hypercapnic respiratory failure (pCO2 \> 60 mmHg at presentation) such as in Chronic Obstructive Pulmonary Disease * Presence of another cause of hypoxemic respiratory failure - e.g. pulmonary embolism, acute respiratory distress syndrome (ARDS), pulmonary oedema * Hemodynamic instability with necessity for use of inotropes and/or vasopressors * Indication for endotracheal intubation (ETI): Glasgow Coma Scale (GCS) \<8, agitation, device intolerance, respiratory arrest * Immunosuppression (chronic immunosuppressive therapy, clinical history positive for any immunodeficiency - congenital or acquired) * Do Not Resuscitate (DNR) and Do Not Intubate (DNI) indication * Tracheostomy * Nocturnal CPAP ventilation therapy * Any other condition which the clinician would considered an adjunctive risk for taking part in the study or that would not permit the participant to complete it
Where it's running
-
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy Recruiting
Study contacts
- Study coordinator: Andrea Bellone, MD
- Email: andrea.bellone@ospedaleniguarda.it
- Phone: 00396444
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.