Non-invasive Ventilation Versus High Flow Oxygen
Recruiting now · Not applicable
Conditions studied: Pneumonia-associated Acute Hypoxemic Respiratory Failure
In brief
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
Key facts
- Study ID
- NCT03758508
- Run by
- Niguarda Hospital
- People needed
- 128
- Starts
- 2017-11-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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