Actively Recruiting
Non-invasive Ventilation Versus High Flow Oxygen
Led by Niguarda Hospital · Updated on 2026-04-16
128
Participants Needed
1
Research Sites
526 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Non-invasive Ventilation Versus High Flow Oxygen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of pneumonia based on at least two clinical or laboratory criteria plus one radiologic criterion
- Clinical criteria include fever, cough, purulent sputum, or lung exam signs consistent with pneumonia
- Laboratory criteria include leukocytosis (white blood cells >10000/mcL), leukopenia (white blood cells <4000/mcL), or increased inflammatory markers
- Radiologic criteria include consolidations seen on chest X-ray or CT scan
- Hypoxemic respiratory failure with PaO2/FiO2 less than 300 after at least 15 minutes of conventional oxygen therapy with FiO2 ≥ 50%
- Respiratory rate ≥ 25 breaths per minute or use of accessory muscles for breathing
- Informed consent to participate in the study
You will not qualify if you...
- Age under 18 years
- Hypercapnic respiratory failure with pCO2 > 60 mmHg, such as in COPD
- Other causes of hypoxemic respiratory failure like pulmonary embolism, ARDS, or pulmonary edema
- Hemodynamic instability requiring inotropes or vasopressors
- Need for endotracheal intubation due to severe neurological impairment, agitation, device intolerance, or respiratory arrest
- Immunosuppression from chronic therapy or known immunodeficiency
- Do Not Resuscitate or Do Not Intubate orders
- Presence of a tracheostomy
- Use of nocturnal CPAP ventilation therapy
- Any other condition deemed by the clinician as a risk or preventing completion of the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
Research Team
A
Andrea Bellone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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