Rose 2008.
| Methods | ||
| Participants | Mechanical ventilation with volume‐ or pressure‐targeted mandatory modes for > 24 hours Drager Evita XL ventilator with SmartCare™/PS (v 1.1) software available for use immediately before randomization PEEP ≤ 8 cm H2O P/F ratio > 150 mmHg or SaO2 ≥ 90% with FiO2 ≤ 0.50 Plateau pressure ≤ 30 cm H2O Haemodynamic stability (epinephrine or norepinephrine ≤ 16.5 mcg/min or dopamine ≤ 500 mcg/min) Body temperature 36°C to 39°C Stable neurological status with Glasgow Coma Scale > 4 No anticipated requirement for transport or surgery within 2 hours Successful completion of SBT using PS (max 20 cm H2O) to achieve VT > 200 mL |
|
| Interventions | SmartCare™ versus usual care | |
| Outcomes | Time to successful extubation Time to first successful SBT Total duration of mechanical ventilation (from initiation to extubation) Time from meeting criteria for discontinuation to actual extubation Length of ICU stay Length of hospital stay Mortality before separation potential Mortality before successful extubation Use of non‐invasive ventilation following extubation Adverse event: reintubation Adverse event: tracheostomy Prolonged mechanical ventilation > 14 days |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Website‐based (www.randomization.com) computer‐generated randomization |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered, sealed opaque envelopes |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Principal study investigator assessed and recorded study outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data from all randomly assigned participants were included in the analyses |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Did the trial stop early for benefit? | Low risk | Target sample was 222, of which 102 participants were enrolled. Trial was stopped early for futility based on graduate degree requirements and sample size recalculation |
| Participants analysed according to the group allocated to? | Low risk | Analyses were performed on an intention‐to‐treat basis |