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. 2016 Sep 12;2016(9):CD003587. doi: 10.1002/14651858.CD003587.pub3

Simeone 2002.

Methods Parallel‐group randomized controlled trial, conducted in Italy. Study conducted from February 1999 to November 1999
Participants 49 elective coronary artery bypass graft, aortic or mitral valve surgery patients
Interventions Early extubation (weaning protocol with aim of extubation within 9 hours after surgery) in 24 participants
Usual care (weaning according to physicians' subjective clinical judgement) in 25 participants
Physicians decided when to extubate.
Outcomes Risk of tracheal reintubation
Risk of stroke (e.g. aphasia, right side paralysis)
Risk of major bleeding
Risk of acute renal failure
Time to extubation
Length of stay in the ICU
Notes Weaning protocol was the same in both groups, but timing was different, as described in the paper. No power calculation was done. No details about the funding source were given. Details of any declarations of conflict of interest among study authors were not provided.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details given
Allocation concealment (selection bias) Unclear risk No details given
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk No details given
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No participants withdrew from the study.
Selective reporting (reporting bias) Low risk All outcomes collected and reported
Other bias Low risk Preoperative risk score, participants' characteristics, surgical time, illness severity score (APACHE II and III) and preoperative respiratory parameters were comparable between groups.