NCT03643939.

Study name	High‐flow nasal oxygen cannula compared to non‐invasive ventilation in adult patients with acute respiratory failure
Methods	RCT, parallel‐group design
Participants	Estimated number of participants: 1200 Setting: ICU or ED, Brazil Inclusion criteria: age ≥ 18; admitted to ICU or ED; acute onset respiratory distress; Non‐immunocompromised AHRF: hypoxaemia evidenced by SpO2 < 90% or PaO2 < 60 mmHg in room air; use of accessory muscles, paradoxical breathing, and/or thoracoabdominal asynchrony; respiratory rate > 25 breaths/min Immunocompromised AHRF: as non‐immunocompromised AHRF; immunosuppression AECOPD: diagnosis or suspicion of COPD; respiratory rate > 25 breaths/min; pH < 7.35; PaCO2 > 45 mmHg Cardiogenic acute pulmonary oedema: diagnosis of cardiogenic acute pulmonary oedema; respiratory rate > 25 breaths/min; SpO2 < 95% Exclusion criteria: indication for emergency intubation; psychomotor agitation requiring sedation; persistent haemodynamic instability; contraindications to NIV; pneumothorax or extensive pleural effusion; severe arrhythmia; thoracic trauma main cause of AHRF; asthma attack; pregnancy; cardiogenic shock; acute coronary syndrome; AHRF post‐extubation; post‐surgical AHRF; hypercapnic AHRF due to neuromuscular disease or chest deformity; exclusive palliative care; do‐not‐intubate order
Interventions	Intervention group (HFNC): Airvo2, Fisher & Paykel, Auckland, New Zealand Control group (NIV): oronasal or full face mask
Outcomes	All outcomes reported: intubation rate; 90‐day mortality; ICU‐free days; MV‐free days; hospital length of stay; ICU length of stay; vasopressor‐free days; dialysis‐free days Outcomes relevant to this review: intubation rate; mortality; hospital length of stay; ICU length of stay
Starting date	23 August 2018
Contact information	Israel Maia, israels.maia@gmail.com. Leticia Kawano‐Dourado, ldourado@hcor.com.br
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