Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Diagnostic accuracy of non-invasive ICP and compliance parameters
研究概览
简要总结
The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2/P1 ratio and nTTP) obtained with the brain4care system for the screening of intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke treated in Brazil's public health system (SUS).
The main questions it aims to answer are:
Can non-invasive ICP and ICC pulse morphology reliably identify or exclude intracranial hypertension, cerebral edema, and hemorrhage compared to CT findings and clinical/neurological evaluations?
Can this approach differentiate ischemic stroke from hemorrhagic stroke with sufficient accuracy?
Does the use of brain4care contribute to earlier detection, improved clinical decision-making, and cost reduction in emergency settings?
详细描述
This is a prospective, observational, multicenter, longitudinal cohort study conducted in four Brazilian states (Amazonas, São Paulo, Sergipe, and Rio Grande do Sul). The study aims to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) monitoring, using the brain4care system, for screening intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke (ischemic or hemorrhagic) admitted to multiple levels of care in the Brazilian Unified Health System (SUS), including pre-hospital care (SAMU), primary care (UBS), urgent care units (UPA), emergency rooms (PS), and intensive care units (ICUs).
Study Procedures
Eligible participants (≥18 years) with TBI or stroke will undergo daily non-invasive ICP and ICC monitoring using the BWS 2.0 (Braincare Wireless System). Monitoring will be performed by trained medical and nursing teams, adjusted according to care setting:
SAMU (pre-hospital): 5 minutes of valid pulses during stabilization and transport.
UBS, UPA, and PS: 10 minutes of valid pulses during initial evaluation; repeated daily until transfer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of non-invasive ICP and compliance parameters
时间窗: From enrollment up to 14 days in the intensive care unit.
Diagnostic accuracy of non-invasive ICP and compliance parameters (P2/P1 ratio, nTTP) obtained with the brain4care system for detecting intracranial hypertension, assessed by sensitivity, specificity, predictive values, and ROC curve analysis, using neuroimaging and clinical evaluation as reference standards.
次要结局
- Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients(From enrollment up to 14 days in the intensive care unit.)