Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT03758508
Recruiting Not applicable

Non-invasive Ventilation Versus High Flow Oxygen

NCT03758508 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2017-11-01
Last updated
2026-04-16

Condition(s) studied

Pneumonia-associated Acute Hypoxemic Respiratory Failure

Investigational drug(s) / intervention(s)

High Flow Oxygen nasal cannulaNoninvasive ventilation

High Flow Oxygen nasal cannula: High Flow Oxygen nasal cannula

Noninvasive ventilation: In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula

Study summary

The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
ASST Grande Ospedale Metropolitano Niguarda Milan Italy Recruiting

More Niguarda Hospital trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03758508 on ClinicalTrials.gov ↗ ← All trials in Italy