Lellouche 2006.

Methods	Multi‐centre randomized controlled trial
Participants	147 adult patients (intervention 74: control 70) ventilated for ≥ 24 hours using an assisted mode screened for eligibility before usual criteria for weaning were present. Inclusion criteria were: pulse oximetry >90% with FiO2 ≤ 50% and PEEP ≤ 8 cmH2O, no need for epinephrine or norepinephrine at a rate > 1 mg/h, body temperature between 36 to 39 °C, and a stable neurological status with little or no sedation. Eligibility criteria included absence of: a do‐not‐resuscitate order, expected poor short‐term prognosis, tracheostomy, and cardiac arrest with poor neurological prognosis. Setting: 5 teaching hospital medical‐surgical ICUs in 4 countries in Europe (Belgium, Spain, France, Switzerland)
Interventions	Intervention: SmartCare/PS™ Control: Weaning according to local practice (guidelines [weaning protocols] were available in 4/5 ICUs). Ventilator settings were chosen by the physician in charge of the patient. Weaning comprised once daily or more screening for criteria to decide for a SBT (T‐piece or PSV ± PEEP). SBT could be performed as soon as criteria were present; after passing a SBT standard extubation criteria were used.
Outcomes	Time to successful extubation defined as the time from inclusion until successful extubation (followed by 72 hours without ventilator support) Total duration of ventilation Duration of ventilatory support until first extubation Length of ICU stay Length of hospital stay Number of complications in the ICU Number of cases of nosocomial pneumonia ICU mortality Hospital mortality
Notes	Proportion and time to satisfying extubation criteria not reported for usual care arm
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated by blocks of six
Allocation concealment (selection bias)	Low risk	Randomization was centralized, concealed and generated by electronic mail system
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition reported, analysis according to ITT, no missing outcome data
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes are reported
Other bias	Low risk	No other sources of bias detected
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of personnel not possible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unable to confirm if outcome assessors were involved in daily patient care