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. |
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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 |
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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. |