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 |
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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) |
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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 |