NCT03515031.

Study name	High‐flow nasal cannulae vs venturi mask in respiratory failure due to pneumonia
Methods	RCT, parallel‐group design
Participants	Estimated number of participants: 150 Setting: Italy Inclusion criteria: male or female; any ethnic group; age ≥ 18 years; respiratory rate at rest ≥ 30 breaths/minute or presence of respiratory distress; PaO2/ FiO2 ≤ 250 during oxygen therapy; diagnosis of pneumonia as the unique cause of acute respiratory failure; informed consent obtained from the patient or the closest relative Exclusion criteria: other diagnoses (instead of pneumonia) as a cause of acute respiratory failure; unstable angina and acute myocardial infarction in place; acute respiratory acidosis; systolic blood pressure < 90 mmHg unresponsive to fluids or with amines; severe arrhythmias; epileptic seizures; impaired swallowing; craniofacial trauma or burns; unco‐operative patient; presence of open wound (skull, chest, abdomen); respiratory arrest or need for intubation; ongoing pregnancy or suspected
Interventions	Intervention group (HFNC): flow ≥ 60 L/min, FiO2 titrated to target SpO2 ≥ 92% Control group (standard oxygen therapy): Venturi mask FiO2 titrated to target SpO2 ≥ 92% in both groups
Outcomes	All outcomes reported: endotracheal intubation; 30‐day mortality; improvement of respiratory exchanges compared to baseline; arterial blood gas; adverse events; length of hospital stay Outcomes relevant to this review: endotracheal intubation; 30‐day mortality; arterial blood gas; adverse events; length of hospital stay
Starting date	3 May 2018
Contact information	Roberto Cosentini, Papa Giovanni XXIII Hospital
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