Stahl 2009.

Methods	Randomized controlled trial
Participants	60 adult patients (Intervention 30; Control 30) who were mechanically ventilated via an endotracheal tube or tracheostomy for at least 24 hours, breathing spontaneously, Ramsay sedation score ≤ 3, PaO2 >75mmHg or SaO2 >90% with FiO2 ≤ 0.5, 18‐80 years of age, body weight 35‐200kg. Exclusion criteria comprised: PEEP > 10cmH2O, haemodynamic instability with a need for catecholamines, rectal temperature >39°C, haemoglobin <7g/dL, and pH <7.2.
Interventions	Intervention: SmartCare/PS™ Control: physician‐directed weaning using no strict protocol but recommending PS should be gradually reduced in single steps of no more than 15 cmH2O Extubation criteria: respiratory rate <30 breaths/min, PaO2 >75mmHg or SaO2 >90%, sufficient airway protection, haemodynamic stability
Outcomes	Duration of ventilator weaning (time from switching controlled to assisted breathing (CPAP/ASB mode) until extubation or disconnection (if tracheostomy) Total duration of mechanical ventilation (intubation to successful extubation) Length of ICU stay Reintubation within 48 hours Physician workload (frequency of PS, FiO2 and PEEP setting changes/hour) Nursing workload (frequency of alarms indicating clean CO2 cuvette/hour) ICU and hospital mortality
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization list generated using RITA version 1.13a. Stratified randomization with age and duration of mechanical ventilation prior to weaning
Allocation concealment (selection bias)	Low risk	Opaque sealed envelopes
Incomplete outcome data (attrition bias) All outcomes	Low risk	All a priori outcomes reported. Analysis according to ITT
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes are reported
Other bias	Unclear risk	Sample size calculation states: based on 80% power to detect a 2 days difference in weaning time, α 0.05 requires 54 patients in each group. Unplanned interim analysis was undertaken because of low recruitment after 1 year: sample size and significance levels were recalculated as N = 60. After the 60th patient the trial was stopped for futility
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants, staff and research personnel were unblinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assumed as low risk due to the objective nature of outcomes (weaning commencement/extubation). Communication with authors: outcome assessors were independent from those managing patient care