Outcome measures
’ of mean ICP, RAP
SECONDARY
The primary outcome was the effect of LPV on ICP and PRx. We identified three endpoints:Number and percentage (%) of patients in whom the ICP response to interventions was below the safety limit of 22 mmHg and therefore could complete the whole protocol.‘Noninferiority’ of mean ICP, to be understood as an intervention ICP mean value not exceeding the preceding baseline values by more than 3 mmHg. Hence, an increase in ICP ≥ 3 mmHg was considered clinically significant.No worsening in PRx between the intervention value and the preceding baseline value.The secondary outcome was the effect of LPV on RAP and brain oxygenation, rSO