NCT04036175.

Study name	Comparison of patient work of breathing and tidal volumes with high‐flow nasal cannula oxygen therapy and NIV (non‐invasive ventilation) after extubation in the ICU
Methods	RCT, cross‐over design. Interventions delivered in a random order for 20 minutes each
Participants	Estimated number of participants: 25 Setting: ICU, France Inclusion Criteria: ≥ 18 years of age; planned extubation decided by the physician in charge of the participant after success of weaning trial; at high risk of reintubation (> 65 years of age; underlying chronic cardiac or lung disease); hypoxaemia (PaO2/FiO2 < 300 mmHg under MV before extubation) Exclusion Criteria: duration of MV prior to extubation < 24 hours; contraindication to NIV; contraindication to nasogastric tube; do‐not‐reintubate order at time of extubation; under legal protection; opposition to participate
Interventions	Intervention group (HFNC): flow = 50 L/min Control group (NIV): BiPAP; PEEP = 5 cm H2O, IPAP adjusted to achieve expired tidal volume of 6 to 8 mL/kg FiO2 adjusted to obtain SpO2 ≥ 92% for both groups
Outcomes	All outcomes measured: patient respiratory effort and tidal volume ; respiratory rate; SpO2; transcutaneous PaCO2; transpulmonary pressure; systolic and diastolic arterial pressure; comfort evaluation (visual evaluation scale) Outcomes relevant to this review: patient respiratory effort; respiratory rate; SpO2; transcutaneous PaCO2; comfort level
Starting date	6 March 2018
Contact information	Arnaud W Thille, arnaud.thille@chu-poitiers.fr
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