With 20-year experience of traumatic brain injury (TBI) studies, our research group has obtained one of the largest data bank of TBI (162,734 cases) in the world. Law-enforced helmet usage law began in 1997 and our first edition of clinical practice guidelines (CPG) for severe TBI (STBI) in Taiwan appeared in 2006. In the last stage of our clinical study, we have proved that there are growing evidences about the need of intracranial pressure (ICP) monitoring in the treatment of STBI. However, there are still debates about the optimal cerebral perfusion pressure (CPP), especially in patients with impaired pressure autoregulation. The authors demonstrated that brain tissue oxygen tension (PtO2) monitors, transcranial Doppler (TCD) monitors, CPP, and ICP monitors were associated with improved STBI outcomes. This was the first time that the results of PtO2 monitoring were reported for STBI patients. There has been a growing tendency of consensus about the need of ICP monitoring in the treatment of STBI since 1995. We have now decided to explore further whether the addition of PtO2 monitor in the treatment of STBI will be associated with improved patient outcome. The purposes of this study are (1) to evaluate the survival efficacy of multiple cerebral monitoring; and (2) to investigate the outcome difference with regard to Glasgow outcome scale (GOS), Glasgow outcome scale-Extended (GOSE), and Health Related Quality of Life (HRQL) among patients with different monitoring groups. This prospective, multi-center, randomized-controlled study will deal with TBI patients in 5 medical centers, enrolling STBI patients with Glasgow Coma Scale (GCS) scores 3 to 8, aged 17-70 years. All the subjects will be randomized and divided into two groups: the study group (Gr. A) and the control group (Gr. B). We will use multiple cerebral monitoring systems (ICP, brain tissue oxygen, Pt O2, and TCD) in Gr. A. The target of Gr. A. is to adjust CPP to maintain PtO2 around 25-30 mmHg. ICP monitoring only is used in Gr. B. To keep CPP at least at 60 mmHg is the target of Gr. B. The ICP, CPP, mean arterial pressure (MAP) intake, output, PtO2 will be recorded every hour. We will use correlation coefficients between slow waves in CPP and mean flow velocity (MVF), or between and ICP can be used as a determinant of autoregulation at least daily. In 1, 3, 6, 12 months, we will evaluate the outcome by following up with the GOS, in which ‘favorable outcome’ is defined as a good recovery or a moderate disability, and ‘unfavorable outcome’ as a severe disability or a vegetative state. The primary efficacy endpoint is overall survival. The survival function will be estimated using Kaplan-Meier method within each treatment group. Stratified log-rank test will be applied for the comparison between the two treatment groups. The significance level is set at 0.05 (two-sided). The other efficacy endpoints will be analyzed using Cox’s regression model, ANCOVA, Chi-square test, and multiple linear regression. SAS package (9.1 version) is used for statistical analysis. A pilot study with multiple cerebral monitoring systems (PtO2, TCD, CPP and ICP) has been performed in 6 patients with STBI. The preliminary results of Gr.A. have demonstrated a better outcome as compared with Gr. B. in this limited data. Further study is indicated to evaluate the outcome difference in different monitoring groups. We anticipate to show the following results after this study: (1) applying multiple cerebral monitoring in the treatment of STBI will reduce the mortality rate and improve the quality of life in the chronic phase, (2) setting a new guideline helps to train young physicians, and (3) the outcome of STBI patients will be improved with favorable GOS, GOSE, and HRQL.
|Effective start/end date||12/31/10 → 1/31/11|
- traumatic brain injury
- brain tissue oxygen tension
- intracranial pressure
- cerebral perfusion pressure