Table 1.

Study flow chart

Procedures and assessments	From inclusion to the initial SBT	From the initial SBT to extubation	From the initial SBT to day 28	Until ICU discharge and day 90
Inclusion and non-inclusion criteria	X
Information and consent	X			X
Randomisation	X
Characteristics of the patient*	X
Characteristics of the initial SBT†	X
Characteristics at time of extubation‡		X
Characteristics after extubation§			X
Vital status				X

*Characteristics of the patient include age, gender, height, weight, severity score indicated by the Simplified Acute Physiological Score II and the Sepsis-related Organ Failure Assessment score, underlying chronic cardiac or respiratory disease, date and reason for admission/ intubation, duration of intubation prior to the initial SBT, ventilatory settings and blood gases before the initial SBT.

†Characteristics of the SBT include duration, type and settings of the initial SBT, vital parameters at the end of the initial SBT, and criteria for SBT failure.

‡Characteristics at time of extubation include duration of weaning between the initial SBT and extubation, the number of SBTs attempts before extubation, classification according to the weaning difficulty, administrations of steroids before extubation, qualitative assessment of cough strength and amount of secretions at time of extubation.

§Characteristics after extubation include the use and duration of non-invasive ventilation and high-flow nasal oxygen after extubation (as well prophylactic use as rescue therapy to treat postextubation respiratory failure), criteria for postextubation respiratory failure, criteria for reintubation, need for reintubation, number of days of mechanical ventilation (invasive and non-invasive), tracheostomy and death.

ICU, intensive care unit; SBT, spontaneous breathing trial.