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. 2014 Sep 9;2014(9):CD008638. doi: 10.1002/14651858.CD008638.pub2

Bifulco 2008.

Methods  
Participants Ventilated for at least 24 hours
Eligible for discontinuation of mechanical ventilation using usual criteria for weaning readiness
Successful preinclusion test with PS > 15 cm H2O
Interventions SmartCare™ versus conventional weaning protocol (used in ICU)
Outcomes Weaning time (time from randomization to extubation)
Total duration of mechanical ventilation (from initiation to extubation)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐based central randomization (statistics department)
Allocation concealment (selection bias) Low risk Study arm communicated by telephone
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Individuals assessing outcomes were not separate from individuals supervising or administering the study interventions
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Two withdrawals from the SmartCare™ arm were reported, and one withdrawal from the control arm, representing 3 of 30 (10%) participants
Selective reporting (reporting bias) Unclear risk Minimal outcomes collected because of early stopping and limited availability of personnel. Study authors confirmed that they intended to collect data on VAP rate, duration of mechanical ventilation and mortality
Did the trial stop early for benefit? Low risk Stopped early because of limited funding and personnel
Participants analysed according to the group allocated to? Low risk All participants with data were included in the analysis on the basis of treatment assignment. A modified intention‐to‐treat analysis was conducted because of study withdrawals