ABSTRACT Purpose Severe traumatic brain injury (sTBI) is associated with cerebral hypoxia and hemodynamic instability, contributing to secondary brain injury and poor neurological outcomes. This prospective pilot study evaluated whether cerebral near-infrared reflectance spectroscopy (NIRS)-guided monitoring with interventions to maintain the regional cerebral oxygen saturation (rSO 2 ) ≥55% improves outcomes in patients with sTBI. Methods Eighty adult patients with sTBI requiring neurosurgical intervention were prospectively randomized into an intervention group ( n =40) receiving continuous cerebral NIRS monitoring with protocol-guided optimization of rSO 2 , or a control group ( n =40) receiving standard neurocritical care. Eligible patients were aged >20 years with Glasgow coma scale (GCS) scores <8. Baseline demographic and clinical characteristics were comparable between groups. Interventions included optimization of head position, ventilation, mean arterial pressure (MAP), cardiac index, oxygen supplementation, and transfusion when indicated. Primary outcomes included mortality, ICU and hospital length of stay, and complications. Secondary outcomes included neurological recovery assessed using the modified Rankin scale (mRS) and Glasgow outcome scale–extended (GOSE) at 1-year follow-up. Statistical analyses were performed using Chi-square, Fisher’s exact, t -test, Mann-Whitney U tests, etc. Results Hospital mortality was lower in the intervention group than in the control group (45.0% vs. 47.5%, P =0.043). Favorable neurological outcomes (mRS 0–3) at 1 year were significantly more frequent in the intervention group (25.0% vs. 5.0%, P =0.006). No significant differences were observed in ICU length of stay, ventilator-free days, vasopressor-free days, or major complications. Low cardiac index ≤2.0 L/(min·m 2 ) and MAP ≤65 mmHg were independent predictors of mortality. Mean rSO 2 positively correlated with ICU length of stay ( r =0.459, P <0.001). Conclusion NIRS-guided cerebral oxygenation monitoring is feasible and associated with improved long-term neurological outcomes in sTBI patients. Maintaining adequate MAP and cardiac index may be critical for optimizing cerebral oxygenation and reducing mortality risk. Clinical trial registration ClinicalTrials.gov (NCT06306950)
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