Schadler 2012.
| Methods | ||
| Participants | Patients ventilated for > 9 hours at 9:00 am in three ICUs (cardiovascular, interdisciplinary, surgical) serving all surgical disciplines in an academic tertiary hospital. Most patients were included following elective or emergency surgery with small numbers of patients included preoperatively or for non‐surgical reasons. In subgroup analysis, they examined patients who underwent cardiac surgery (n=132), and with sepsis (n=44) or chronic obstructive pulmonary disease (n=41) | |
| Interventions | SmartCare™ versus weaning based on standardized written protocol | |
| Outcomes | Discontinuation time (time from randomization to extubation) Time to successful extubation Time to first SBT Time to first successful SBT Total duration of mechanical ventilation (initiation to extubation) ICU length of stay Hospital length of stay Mortality ‐ 28 day Mortality ‐ 90 day Use of non‐invasive ventilation following extubation Adverse event ‐ reintubation Adverse event ‐ self‐extubation Adverse event ‐ tracheostomy Prolonged mechanical ventilation > 14 days Prolonged mechanical ventilation > 21 days |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | An electronic randomization system was used to generate randomization lists |
| Allocation concealment (selection bias) | Low risk | Allocation reported to be concealed and allocation was disclosed to investigators by sealed envelopes containing patient numbers such that patient one received study envelope one |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The authors randomized 317 patients for which consent could not be obtained in 17 patients. Reported analyses included all 300 randomized patients for which consent was obtained. Withdrawals by treatment group were not reported |
| Selective reporting (reporting bias) | Low risk | No evidence of selective outcome reporting |
| Did the trial stop early for benefit? | Low risk | Trial did not stop early for benefit |
| Participants analysed according to the group allocated to? | Low risk | Yes |