BACKGROUND Intracranial pressure (ICP) monitoring remains a cornerstone recommendation in the management of severe traumatic brain injury (sTBI), as outlined by the Brain Trauma Foundation (BTF). Classified as a Level IIb recommendation, ICP monitoring is advocated to detect and manage intracranial hypertension, a critical determinant of outcomes in TBI. This recommendation reflects moderate-quality evidence supporting its use to guide therapeutic decisions and improve patient care. However, the clinical efficacy of ICP monitoring in improving survival and functional recovery remains a topic of ongoing debate. While guidelines endorse its integration into standard care protocols, evidence from studies such as the BEST TRIP trial Chesnut et al.1 has questioned its superiority over approaches based solely on imaging and clinical assessments. In addition, advancements in multimodal approaches, including the integration of ICP monitoring with brain oxygenation, as evaluated in the BOOST-II study Okonkwo et al.,2 suggest potential improvements in functional outcomes and survival. These findings are promising but underscore the necessity of larger trials to validate such strategies. Furthermore, considerations around complications associated with ICP monitoring, though minimal in experienced centers, and the economic implication of prolonged ICU stays demand careful evaluation. This meta-analysis aimed to consolidate the available evidence on the impact of ICP monitoring on key clinical outcomes, including mortality, functional recovery, and monitoring-related complications. By synthesizing data from pivotal studies, this review seeks to clarify the role of ICP monitoring in contemporary TBI management and identify priorities for future research. METHODS The study was designed following the Cochrane Collaboration Handbook for Systematic Review of Interventions and the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) reporting guidelines. Eligibility criteria We restricted inclusion in this meta-analysis to randomized controlled trials (RCTs) that compared patients’ ICP monitoring or non-monitoring after severe traumatic brain injury (GCS 3-8). The included studies were required to report at least one of the following outcomes of interest: (1) functional outcomes (neurological recover GCS>8); (2) complications related to ICP monitoring; (3) length of stay in the Intensive Care Unit (ICU); (4) control of intracranial pressure; (5) mortality. We excluded studies that do not perform analysis only of invasive and non-invasive intracranial pressure measurements. Search strategy and data extraction We systematically searched the United States National Library of Medicine (PubMed), Embase, and the Cochrane Central Register of Controlled Trials from inception to November 2024 using the following search strategy: (Severe Traumatic Brain Injury" OR "Severe Head Injury") AND ("Intracranial Pressure Monitoring" OR "ICP Monitoring" OR "Intracranial Pressure Device") AND ("Clinical Outcomes" OR "Mortality" OR "Functional Recovery" OR "Complications). We extracted the data from individual studies according to predefined search criteria. Disagreements were resolved by consensus among the authors. Endpoints and subgroup analysis The primary outcome of interest was mortality for any cause and functional outcome based on the Glasgow Outcome Scale Extended (GOS-E). Secondary outcomes of interest included length of stay in the ICU (Medium) and control of intracranial Pressure (typically ≤20 mmHg). We performed a subgroup analysis comparing the effects of eptifibatide as an adjuvant therapy to thrombolysis versus thrombolysis alone. Quality assessment The quality assessment of the RCTs was performed using Cochrane’s Risk of Bias 2 (RoB 2) tool11. This evaluation classifies studies as high, medium (some concerns), or low regarding bias within five domains. Two independent reviewers (G. S and A. L. M. S.) conducted the quality assessments, which were then reviewed and approved by a third (S.S). Statistical analysis We evaluated treatment effects for binary endpoints using pooled relative risk (RR) and odds ratios (OR), each with 95% confidence intervals (95%CI). Effect size variation and heterogeneity were evaluated through I2 and Tau2 statistics. We used a fixed-effect model for endpoints with I2 40 years, motor posturing, or hypotension).5 Evidence from the DECRA trial demonstrated that decompressive craniectomy reduced ICP and ICU length of stay but was associated with worse functional outcomes at six months post-injury.3 Conversely, the RESCUEicp trial found that late decompressive craniectomy in patients with refractory ICP elevation led to increased survival, though with a higher proportion of patients in a vegetative or severely disabled state.4 The BEST TRIP study, unique in being conducted in low- and middle-income countries (LMICs), compared ICP-guided therapy to a protocol based on imaging and clinical examination and found no significant difference in mortality or functional outcome.1 This raised concerns about the universal applicability of ICP monitoring, particularly in resource-limited settings. The BOOST-II trial suggested that ICP-guided therapy augmented with brain tissue oxygen (PbtO2) monitoring might improve outcomes, though definitive conclusions require further studies.2 Although ICP monitoring allows more targeted and dynamic management, its effect on long-term outcomes is still debated. Factors such as timing, thresholds, multimodal monitoring, and individual patient characteristics likely play roles in outcomes. The heterogeneity in study designs and patient populations also contributes to conflicting results. CONCLUSION This systematic review and meta-analysis of four major RCTs — BEST TRIP, DECRA, RESCUEicp, and BOOST-II — highlights the complexity and nuance of using ICP monitoring in the management of severe TBI. While current BTF guidelines support its use in specific patient populations, the evidence suggests that ICP monitoring alone may not be sufficient to improve outcomes unless coupled with protocolized and responsive treatment strategies. The variability in outcomes across trials underscores the need for individualized patient-centered approaches, considering local resources, patient demographics, and injury severity. Further high-quality multicenter trials are warranted to refine the indications and methodologies of ICP monitoring, integrating newer technologies and outcome metrics. The inclusion of long-term neurocognitive and quality-of-life outcomes will be essential to fully understand the benefit of ICP monitoring in severe TBI care.
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