Severe traumatic brain injury (TBI) is a leading cause of death and disability. Monitoring intracranial pressure (ICP) is recommended, but the data on the outcomes are conflicting. Adding continuous brain tissue oxygen partial pressure (PbtO2) monitoring may have some benefit but the OXY-TC suggested it did not improve 6-month neurological outcomes. This single-center pilot randomized controlled study aimed to evaluate whether adding PbtO2 monitoring was feasible and could improve the prognosis of severe TBI. The participants were randomized into either an ICP alone or an ICP + PbtO2 group for 7 days, with treatment protocols based on existing guidelines. Clinical parameters were collected hourly. The primary outcome was the feasibility of using PbtO2 monitoring. The secondary outcomes were 6-month survival, analyzed by the log-rank test, the 3- and 6-month Glasgow Outcome Scale (GOS) scores, compared between groups by chi-squared test. Seventy patients were included (36 ICP, 34 ICP + PbtO2). The ICP + PbtO2 group had lower mean daily ICP (13.4 vs. 18.2 mmHg, P = 0.0024) and higher mean daily cerebral perfusion pressure (82.1 vs. 74.5 mmHg, P = 0.0055). The ICP + PbtO2 group had higher 6-month survival (79.4 % vs. 55.6 %, P = 0.0337) and more favorable outcomes at 3 months (67.6 % vs. 38.9 %, P = 0.0160) and 6 months (70.6 % vs. 41.7 %, P = 0.0149). Adding PbtO2 monitoring to ICP monitoring is feasible in patients with severe TBI and could maybe improve the intermediate-term outcomes. The results will serve to design larger trials.
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