NCT03632577.

Study name	High‐flow oxygen (HFO) versus non‐invasive ventilation (NIV) associated to automated flow oxygen titration (AFOT) after extubation in patient with respiratory risk: non‐inferiority prospective comparative study
Methods	RCT, parallel‐group design
Participants	Estimated number of participants: 60 Setting: ICU, France Inclusion criteria: respiratory disease due to suspected or proved COPD, asthma, bronchiectasis, cystic fibrosis, interstitial pneumonia, obstructive insufficient respiratory, restrictive insufficient respiratory; extubation scheduled; informed consent given; affiliated to social insurance Exclusion criteria: pregnancy; moribund; previous home NIV (not CPAP); tracheostomy; participant under trusteeship, guardianship or safeguard of justice
Interventions	Intervention group (HFNO) Control group (NIV): BiPAP
Outcomes	All outcomes measured: comfort; dyspnoea; treatment failure; PaO2; PaCO2; length of hospital stay; length of ICU stay; 1‐month mortality; 3‐month mortality; ICU mortality; hospital mortality; use of another device in 72 hours; respiratory congestion; intubation rate at 48 hours; intubation rate at 72 hours; SpO2 stability Outcomes relevant to this review: discomfort; dyspnoea; treatment failure; PaO2; PaCO2; length of hospital stay; length of ICU stay; 3‐month mortality
Starting date	15 August 2018
Contact information	Elise Noel‐Savina, noel‐savina.e@chu‐toulouse.fr
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