EEG Controlled Triage in the Ambulance for Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 2
- 主要终点
- The diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke in the prehospital setting expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
研究概览
简要总结
Endovascular thrombectomy (EVT) is the standard treatment for patients with a large vessel occlusion (LVO) stroke. Direct presentation of patients with an LVO to a comprehensive stroke center (CSC) reduces onset-to-treatment time by approximately an hour and thereby improves clinical outcome. However, a reliable tool for prehospital LVO-detection is currently not available. Previous electroencephalography (EEG) studies have shown that hemispheric hypoxia quickly results in slowing of the EEG-signal. Dry electrode EEG caps allow reliable EEG measurement in less than five minutes. We hypothesize that dry electrode EEG is an accurate and feasible diagnostic test for LVO in the prehospital setting.
ELECTRA-STROKE is a diagnostic pilot study that consists of four phases. In phases 1, 2 and 3, technical and logistical feasibility of performing dry electrode EEGs are tested in different in-hospital settings: the outpatient clinic (sample size: max. 20 patients), Neurology ward (sample size: max. 20 patients) and emergency room (sample size: max. 300 patients), respectively. In the final phase, ambulance paramedics will perform dry electrode EEGs in 386 patients with a suspected stroke. The aim of the ELECTRA-STROKE study is to determine the diagnostic accuracy of dry-electrode EEG for diagnosis of LVO-a stroke when performed by ambulance personnel in patients with a suspected AIS. Sample size calculation is based on an expected specificity of 70% and an incidence of LVO stroke of 5%.
详细描述
RATIONALE
Endovascular thrombectomy (EVT) is standard treatment for acute ischemic stroke (AIS) if there is a large vessel occlusion in the anterior circulation (LVO-a). Because of its complexity, EVT is performed in selected hospitals only. Currently, approximately half of EVT eligible patients are initially admitted to hospitals that do not provide this therapy. This delays initiation of treatment by approximately an hour, which decreases the chance of a good clinical outcome. Direct presentation of all patients with a suspected AIS in EVT capable hospitals is not feasible, since only approximately 7% of these patients are eligible for EVT. Therefore, an advanced triage method that reliably identifies patients with an LVO-a in the ambulance is necessary. Electroencephalography (EEG) may be suitable for this purpose, as preliminary studies suggest that slow EEG activity in the delta frequency range correlates with lesion location on cerebral imaging. Use of dry electrode EEG caps will enable relatively unexperienced paramedics to perform a reliable measurement without the EEG preparation time associated with 'wet' EEGs. Combined with algorithms for automated signal analysis, we expect the time of EEG recording and analysis to eventually be below five minutes, which would make stroke triage in the ambulance by EEG logistically feasible.
HYPOTHESIS
We hypothesize that EEG accurately identifies the presence of an LVO-a stroke in patients with a suspected AIS when applied in the ambulance.
OBJECTIVE
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
The diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke in the prehospital setting expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
时间窗: The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.
The diagnostic accuracy of dry electrode cap EEG to discriminate LVO-a stroke from all other strokes and stroke mimics in the prehospital setting (study phase 4) expressed as the area under the receiver operating characteristics (ROC) curve of the theta/alpha ratio.
次要结局
- Sensitivity of dry electrode EEG for diagnosis of LVO-a(The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.)
- Positive predictive value of dry electrode EEG for diagnosis of LVO-a(The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.)
- Logistical feasibility of performing dry electrode EEGs in the ambulance(Feedback on logistical issues by the paramedic that performs the EEG, will be collected directly at arrival in the emergency department (within 24 hours after the patient is included in the study).)
- Algorithms with an optimal diagnostic accuracy for LVO-a detection in suspected AIS patients with ambulant dry electrode cap EEG.(The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.)
- Negative predictive value of dry electrode EEG for diagnosis of LVO-a(The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.)
- Technical feasibility of performing dry electrode EEGs in the ambulance(Feedback on technical issues by the paramedic that performs the EEG and by the EEG-expert, will be collected directly at arrival in the emergency department (within 24 hours after the patient is included in the study).)
- Specificity of dry electrode EEG for diagnosis of LVO-a(The presence or absence of an LVO-a will be assessed based on CT angiography data obtained at the emergency department (within 24 hours after inclusion in the study). EEG data will be collected at baseline.)
研究者
Jonathan Coutinho
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)