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. 2014 Jun 10;2014(6):CD009235. doi: 10.1002/14651858.CD009235.pub3

Walkey 2011.

Methods Single centre randomized controlled trial
Participants 33 adult patients (15 intervention; 18 control) receiving mechanical ventilation via an endotracheal tube for >48 hours
Setting: USA, medical ICU
Interventions Intervention: SmartCare/PS™
Control: weaning according to usual care
Outcomes Duration of weaning assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation)
Hospital mortality
Complications (death during wean, ventilator‐associated pneumonia during wean, self extubation, reintubation)
Notes This trial was terminated early due to slow recruitment
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Online random number generator
Allocation concealment (selection bias) Low risk Opaque envelopes used
Incomplete outcome data (attrition bias) 
 All outcomes High risk Study terminated early due to slow recruitment. Limited reporting of outcome data
Selective reporting (reporting bias) Unclear risk Study terminated early due to slow recruitment. Limited reporting of outcome data
Other bias Unclear risk Study terminated early due to slow recruitment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible due to nature of intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Unable to confirm if outcome assessors were also involved in the daily care of patients