| Study characteristics |
| Methods |
Method of randomisation: randomisation was based on EEG technician availability.
Blinding: not reported
Cross‐overs: none
Exclusions during trial: none
Loss to follow‐up: none |
| Participants |
Australia
131 participants, 142 operations
EEG/pressure monitoring: 72 operations
Pressure assessment alone: 70 operations
Age: 36 to 70 years, mean 58 years
Gender: 70% male, 30% female
Comparability: age, gender, vascular risk factors similar between 2 groups
More asymptomatic ipsilateral arteries in pressure group: 1% versus 11%
Contralateral artery stenosis unknown |
| Interventions |
Treatment: EEG monitoring and carotid stump back pressure assessment; shunt selected if ipsilateral EEG change (loss of voltage/activity) within 3 minutes of clamping and back pressure < 50 mmHg
Control: carotid stump back pressure assessment alone; shunt selected if back pressure < 50 mmHg
All operations under general anaesthetic; unknown patching rate |
| Outcomes |
Death plus stroke‐related death, any stroke (during the operation), ipsilateral stroke, haemorrhage from operation site, nerve palsies, number of shunted arteries |
| Notes |
Exclusion: none
Follow‐up: duration unknown |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Quote: "Randomization was dependent on availability of an EEG technician". |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not reported |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not reported |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing data |
| Selective reporting (reporting bias) |
Unclear risk |
Study authors did not report prespecified outcome. |
| Other bias |
Low risk |
No other potential biases |
