ICP monitoring in cranial trauma-abandonment or a new beginning?

  Intracranial pressure monitoring (ICP) has been used in clinical practice for more than 50 years, and despite the lack of Class I evidence, ICP monitoring is recommended as one of the routine monitoring tools in both domestic and international guidelines for the management of craniocerebral trauma. However, the results of the Benchmark Evidence from South America Trials: Treatment of Intracranial Pressure (BEST:TRIP) study, published in the New England Journal of Medicine in December 2012, have attracted the attention of scholars both inside and outside the country. The results of the Benchmark Evidence from South America Trials: Treatment of Intracranial Pressure (BEST:TRIP) study have attracted the attention of scholars both nationally and internationally. This is the first randomized, controlled, prospective study of ICP monitoring in the evaluation of the efficacy of heavy craniocerebral trauma, which concluded that a treatment model that focused on controlling ICP to ≤20 mmHg was not superior to a treatment model with imaging and clinical monitoring in patients with heavy craniocerebral trauma.  How can the results of this study be accurately interpreted? Do clinicians need to change their current monitoring and treatment strategies for craniocerebral trauma? That is, does ICP monitoring need to continue to be applied as one of the routine monitoring tools when treating patients with craniocerebral trauma?  Many scholars have interpreted the study, and although there is no controversy about its methodology, short-term results and conclusions, there are many different interpretative views and opinions on the application of ICP monitoring. Combining the literature and the author’s experience, the main controversial issues at present are discussed and summarized as follows.  I. Lack of generalizability The BEST:TRIP study was conducted in four Bolivian and two Ecuadorian hospitals in South America. The economic and medical constraints make the following variability in this RCT study: (1) the inadequacy of prehospital emergency care makes it impossible for more seriously injured patients to receive timely treatment and die immediately outside the hospital (the mortality rate in this region is two to three times higher than that in areas with perfect prehospital emergency care), so the enrolled patients in this group may have relatively mild injuries, and there may also be hypoxia, hypotension, and other factors that aggravate the occurrence of secondary brain damage factors, and the enrolled patients may lose the best time for the intervention treatment to play a role; (2) the comprehensive facilities and treatment level of ICU differ from those of developed countries and regions, while perfect trauma monitoring treatment can effectively reduce the mortality rate of craniocerebral trauma has been confirmed; (3) due to the lack of rehabilitation treatment, the injured cannot receive effective follow-up treatment after leaving ICU and being discharged from hospital, and the long-term follow-up treatment of craniocerebral trauma patients follow-up results are greatly influenced by follow-up treatment; (4) ICP monitoring has not been routinely carried out in the region, so the limitations of the investigators’ inexperience in managing ICP monitoring and guiding clinical diagnosis and treatment in this study may limit the embodiment of the role of ICP monitoring; (5) only 37% of the ICP monitoring group had an initial ICP ≥20 mmHg, and some patients without effective prehospital emergency measures were were brought to the hospital after 1 h post-injury, such patients may have no significant differences in the treatment itself for ICP control exist, or the time to reflect the differences in interventions has been lost. The aforementioned variability calls into question the generalizability of the BEST:TRIP study.  II. Limitations of monitoring methods and monitoring timeframe Both domestic and international guidelines for ICP monitoring in cranial trauma use intracerebroventricular ICP monitoring as the first choice, with the advantage that monitoring ICP while draining CSF contributes to the control of intracranial hypertension. In contrast, the BSET:TRIP study used intracerebral parenchymal ICP monitoring, and the proportion of extraventricular drainage used in this study was only 1% and 2% in the two groups, respectively, which obviously limits the role of drainage of CSF in controlling increased ICP after craniocerebral trauma.  Although there is a lack of a standardized view on the time course of ICP monitoring after craniocerebral trauma in terms of indications for stopping monitoring, theoretically it should be discontinued only after the peak of cerebral edema. The literature reports that the peak period of intracranial hypertension after heavy craniocerebral trauma varies widely from 1 d to 2 weeks. in a study of 191 patients with heavy craniocerebral trauma admitted within 6 h of injury using ICP monitoring for more than 7 d, Stein et al. found that 97.9% of patients had intracranial hypertension, and the mean number of ICP and ICP >20 mmHg and >30 mmHg in the 84-180 h postinjury interval percentages, were significantly higher than within 84 h post-injury (p < 0.01), and there was a significant correlation between increased ICP and poor prognosis after 84 h post-injury (p < 0.05). This study showed an increase in ICP early after heavy craniocerebral trauma, but the peak was in the second half of the acute phase, and this result is revealing for the determination of both ICP and the time course of intensive care treatment in heavy craniocerebral trauma.  However, the mean duration of monitoring in the ICP monitoring group in the BEST:TRIP study was only 3.6 d (2.0 to 6.6 d), and the text does not specify the indication for discontinuing monitoring and how ICP assessment and related treatment were subsequently performed; moreover, the mean duration of treatment in the ICU for the ICP monitoring group was 12 d, which was longer than the mean duration of 9 d for the conventional monitoring group, but the control of ICP in the ICU targeted treatment was significantly shorter in the former than in the latter (3.4d: 4.8d, p = 0.002). It is possible that there was a short duration of monitoring and a return to empirical treatment for ICP after stopping ICP monitoring, which led to a longer duration of treatment in the ICU.  Third, the singularity of the intervention threshold in the ICP monitoring group In the BEST:TRIP study, 20 mmHg was used as the treatment threshold or target in the ICP monitoring group regardless of the surgical treatment or not and the stage of the disease course, which is a necessary method in RCT studies but completely expels the fact that individual differences exist in different patients, which is one of the main flaws of this study. In patients who have had surgical removal of the bone flap for decompression, an ICP of 20 mmHg may already be a low pressure; whereas in those with temporal lobe brain contusion, an ICP of 20 mmHg may be the state that will lead to brain herniation. Again, an intervention threshold of 20 mmHg may be overmedication for the former and undermedication for the latter. As early as 2007 Miller et al. highlighted the uncertainty of ICP thresholds in patients with craniocerebral trauma and the need to adapt treatment protocols to individualized status based on their findings. Meanwhile, many scholars have pointed out that the intervention threshold setting of 20 mmHg may not reflect the presence of treatment differences in the BEST:TRIP study itself due to the relatively mild injuries of the enrolled patients (initial ICP >20 mmHg in only 37%).  IV. other controversies Due to the small sample size, there is a high risk of type II statistical error in the BEST:TRIP study, as the sample size of 324 cases to obtain a 10% increase in good prognosis for GOS has an impact efficacy of only 40%. Also the main prognostic assessment in this study, a weighted method of 21 tests was used, 12 of which were neuropsychological tests, and the results of neuropsychological tests and the time point of post-injury assessment were highly influential; it may be more reasonable to use or combine the use of the more commonly applied modified Rankin score assessment.  Included in the enrollment were those with an initial GCS of 8 or more and subsequent deterioration in their conscious state; this group of patients may have more severe secondary injuries, and their prognosis is inherently different from those with an initial GCS of 8 or less in terms of injury status, and statistical analysis of subgroups should be performed.  A very noteworthy issue was the significant difference (<0.01) between the intensity of ICP-lowering treatment and the duration of treatment in the ICU only used in the ICP monitoring group and the conventional monitoring group. the mean duration of ICP-lowering treatment in the ICU was 3.4 d (1.1-7 d) in the ICP monitoring group compared with 4.8 d (2.3-7.4 d) in the conventional monitoring group. The conventional monitoring group used more hypertonic saline and hyperventilation during ICU treatment, while the ICP monitoring group used more barbiturate therapy. Significant differences in the intensity and approach to reducing ICP therapy exist and may affect the statistical outcome of the prognosis of both groups.  V. Implications of the BEST:TRIP study and the application of ICP monitoring and research directions Does the publication of the results of the BEST:TRIP study mean that ICP monitoring in craniocerebral trauma should be reduced or discontinued? The vast majority of scholars, including the authors of this study, believe that the value of ICP monitoring in the diagnosis and management of craniocerebral trauma should not be denied as a quantitative monitoring indicator to assess ICP status, detect the onset of progressive damage at an early stage, predict prognosis, and guide the adjustment of treatment strategies and approaches. absence of evidence to evidence of absence. Given that the BEST:TRIP study was Level I evidence and that the results showed no statistical difference between the clinical prognosis of the ICP monitoring group and that of the conventional monitoring group, the overwhelming majority of scholars believe that current clinical and research efforts should not be influenced to reduce or discontinue the use of ICP monitoring and return to empirical treatment. In the absence of ICP monitoring, relying only on clinical and imaging assessment, for those who are critically injured and already treated with sedation, inotropes, and hypothermia, if clinical changes are detected, it is necessary to discontinue these treatments and move the patient for the appropriate examination, which causes more serious damage to the patient such as rebound of increased ICP.  Farahvar et al. reported the results of a prospective review of data from 20 trauma centers treating heavy craniocerebral trauma, in which 1202 ICP-monitored patients were compared with 244 non-ICP-monitored patients during the same period, and the mortality rate at 2 weeks post-injury was 19.6% in the ICP-monitored group, which was significantly lower than the 33.2% in the non-ICP-monitored group (p=0.02). They concluded that ICP monitoring should be guided in ICP-targeted treatment of heavy cranial trauma.  Many scholars believe that the results of the BEST:TRIP study provide many insights into the diagnosis and treatment of craniocerebral trauma and point the way for future research: (1) the individual variability of patients with craniocerebral trauma is great, and so far we lack precise knowledge and mastery of the pathophysiological process of increased ICP after craniocerebral trauma; (2) the value of ICP monitoring does not only lie in the numerical value (number (2) The value of ICP monitoring does not only lie in the number, but also in the signal, which conveys information about the intracranial compensatory reserve and cerebrovascular reactivity, and this valuable information has not yet been fully understood, popularized, and used to guide clinical diagnosis and treatment protocols. (3) The current guidelines and clinical practice are too simplistic in the concept of diagnosis and treatment of increased ICP after craniocerebral trauma, and the ICP intervention threshold of 20 mmHg may be too low or not applicable to all patients and for the entire duration of the disease, and more emphasis should be placed on individualized adjustment of the diagnosis and treatment plan; just as reasonable cerebral perfusion pressure in the range of 60 to 90 mmHg range, determining the patient's individualized critical ICP (Critical ICP) is crucial for the selection of the patient's treatment strategy, and perhaps it is more reasonable for this threshold to be 25 mmHg or 30 mmHg; (4) Integrating the post-injury GCS, imaging findings, and clinical assessment to screen different subgroups of patients with craniocerebral trauma in order to refine the ICP monitoring in the diagnosis and treatment (5) The application and study of ICP monitoring should be combined with diversified other monitoring techniques and means, such as cerebral oxygen monitoring, cerebral microdialysis, cerebral blood flow monitoring and electroencephalography monitoring, in order to assess whether brain tissue can maintain effective energy metabolism and oxygen component supply and ensure overall and (6) BEST: The results of the TRIP study, although not confirming a statistical difference in improved prognosis in the ICP monitoring group, showed a trend toward improved prognosis (mortality rates at 14 d post-injury were 21% and 30% for the ICP monitoring group and the conventional monitoring group, respectively; mortality rates at 6 months post-injury were 39% and 44%, respectively, while the good prognosis rates were 44% and 39%, respectively). This result does not mean that the combination of ICP monitoring with clinical and imaging monitoring is not an effective strategy, which is one of the directions for future clinical research.  It is important to emphasize that ICP monitoring is one of the few methods available to date to directly monitor functional status of the brain and does not in itself change the final prognosis of the patient. Instead, it is possible to obtain a change in outcome by using necessary and effective interventions before irreversible brain damage occurs, based on the values and waveform trends provided by ICP monitoring and the effective interpretation of the information conveyed about intracranial compensatory reserve and cerebrovascular reactivity, as interventions should be performed as early as possible in cases of intracranial hypertension. Therefore the application of ICP monitoring for the diagnosis and treatment of cranial trauma is the answer to headstone or a new head start and should be the latter.