Lim 2012.
| Methods | ||
| Participants | Single‐centre study involving a coronary care unit and including participants between 21 and 85 years of age, with stable neurological status, on an assisted mode of mechanical ventilation for > 24 hours Excluded:
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| Interventions | Participants were randomly assigned 1:1 to knowledge‐based weaning (SmartCare™) or usual care APACHE II score was used to stratify illness severity |
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| Outcomes | Primary outcome: total weaning time (from inclusion to extubation without reintubation for 72 hours) Adjusted for APACHE II score Total duration of mechanical support |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered, sealed envelopes held by trial co‐ordinator/RRT or designate |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study co‐ordinators collected outcome data |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participant withdrew from the study. Only one death prevented computation of time to extubation. Total of 5 deaths occurred during the study |
| Selective reporting (reporting bias) | Unclear risk | Yes, reported outcomes were limited in this abstract publication. Study author provided additional data for the 62 participants ultimately included in this trial (originally 54 participants) and reported time to successful extubation and total duration of mechanical ventilation |
| Did the trial stop early for benefit? | Low risk | Stopped early for futility. Investigators sought to recruit 75 participants per study arm |
| Participants analysed according to the group allocated to? | Low risk | Yes. No participant was withdrawn following randomization, and no cross‐overs occurred; however, 1 participant who died was excluded from the outcome analyses |