Weatherburn 2007.
| Methods | Single‐centre randomized controlled trial. Study period: September 2004 to July 2005 | |
| Participants | Adult mechanically ventilated patients in a surgical and general ICU at the Alfred Hospital, a tertiary level teaching hospital in Melbourne, Australia . Total 50 patients, 66% male, mean age 53 years, median APCHE II score was 14. Sedation protocol: Not described. Sedative agents used were morphine and midazolam. Target Bispectral Index (BIS) score greater than 70 | |
| Interventions | BIS monitoring (N = 25) versus Clinical assessment (N = 25). BIS monitoring readings were recorded hourly. Clinical assessment was done by nurses based on heart rate, blood pressure, conscious level and pupillary size, however frequency of monitoring is not mentioned | |
| Outcomes | Intensive care unit length of stay, duration of mechanical ventilation, amount of sedative agents administered (total daily dosage of morphine and midazolam with mean and range), were reported, no other secondary outcome of interest for the review was reported | |
| Notes | Funding sources included Abbott Australasia and BIS monitors and sensors from the manufacturers. The supporters of the study had no role in the study concept, design, data collection, data analysis, data interpretation or writing of the reports. No conflict of interest reported Contacted authors for more details, author not working in the institution any more and study archived hence no details available |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: Patients were randomized using sealed opaque pre‐coded envelopes Comment: Probably done |
| Allocation concealment (selection bias) | Low risk | Quote: Patients were randomized using sealed opaque pre‐coded envelopes Comment: Done |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned, however not possible to blind in this type of study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No information given about blinding of outcome assessment, but review authors judge that the outcome reported is not likely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for all patients reported |
| Selective reporting (reporting bias) | Low risk | Study protocol is available and all of the study's pre‐specified (primary and secondary) outcomes were reported . |