Clinical Evaluation of Pre-hospital Stroke Triage Devices - Electroencephalography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of StrokePointer for LVO stroke
研究概览
简要总结
Endovascular thrombectomy (EVT) is the standard treatment for large vessel occlusion (LVO) strokes, but it can only be performed in specialized hospitals. Since ambulance personnel cannot determine if a patient is eligible for EVT, 54% of LVO stroke patients are initially taken to non-EVT-capable hospitals, resulting in an average delay of 1 hour in time-to-EVT in the Netherlands. To reduce this delay, it is crucial for ambulance personnel to identify potential LVO stroke patients and directly transport them to EVT-capable hospitals. Dry electrode electroencephalography (EEG) has shown high diagnostic accuracy for detecting LVO strokes, but in 32% of patients, the EEG signal quality was too poor to analyze.
To address this issue, TrianecT developed StrokePointer, a portable EEG-based triage device designed to collect and analyze EEG data in patients with suspected acute stroke. The objective of this study is to validate the effectiveness and safety of StrokePointer in detecting LVO stroke among patients with a suspected stroke in the pre-hospital setting.
详细描述
RATIONALE Endovascular thrombectomy (EVT) is the standard treatment for large vessel occlusion (LVO) stroke. However, EVT can only be performed in specialized hospitals and its effect on functional outcome rapidly decreases with passing time (time = brain). Since ambulance personnel cannot determine whether a patient has a stroke that is eligible for EVT, 54% of patients with an LVO stroke are primarily presented at a non-EVT capable hospital. These patients then require interhospital transfer, resulting in average delay in time-to-EVT of 1 hour in the Netherlands. Therefore, providing ambulance personnel with tools to identify patients with a possible LVO stroke in the ambulance, allowing direct transport to an EVT capable hospital, is much needed. Dry electrode electroencephalography (EEG) has shown to have a high diagnostic accuracy for LVO stroke detection among patients with a suspected stroke (area under the receiving operating curve [AUC]: 0.91). However, in 32% of patients EEG signal quality was too poor to analyse. A new portable EEG-based triage device (StrokePointer) has been developed by TrianecT with the aim to collect and analyse EEG data in patients suspected of acute stroke. In this study, we intend to validate the safety and effectiveness of the device.
HYPOTHESIS:
- StrokePointer device can measure EEG data of sufficient quality in >85% of patients, and has a good diagnostic accuracy (AUC>0.8) for LVO stroke detection in the pre-hospital setting.
- Usability of StrokePointer device is rated as "good" on average by ambulance personnel.
- StrokePointer is safe to use in an acute care setting.
OBJECTIVE Primary objective is to validate the data quality and diagnostic accuracy of StrokePointer to detect LVO stroke among patients with a suspected stroke in the pre-hospital setting.
STUDY DESIGN CROSSROADS-EEG is an investigator-initiated, prospective, multi-centre cohort study.
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
- •Suspected acute stroke as per judgement of the ambulance personnel.
- •Age 18 years or older.
- •Onset of symptoms (or last seen well) <24 hours.
- •Written informed consent by patient or legal representative (deferred).
排除标准
- •- Injuries or infections of the scalp in the area of the electrode headset placement.
研究组 & 干预措施
Dry electrode StrokePointer EEG
All patients that are included in the study will undergo a dry electrode electroencephalography (EEG).
干预措施: Dry electrode EEG (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of StrokePointer for LVO stroke
时间窗: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Diagnostic accuracy of StrokePointer for LVO stroke among patients with a suspected stroke, as measured with Area under the curve (AUC) as well as sensitivity and specificity
Data quality of StrokePointer
时间窗: EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.
Proportion of patients with a technically successful EEG dataset: at least 20 seconds of usable EEG (at least 3 electrodes with good skin-electrode quality on either side, no movement artifacts, no muscle artifacts) within a measurement time of 3 minutes.
次要结局
- Predictive value of StrokePointer in identifying LVO stroke(EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.)
- User friendliness(EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.)
- Incidence of serious adverse device-related events (Safety of StrokePointer)(EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.)
- Diagnostic accuracy for identifying LVO stroke subgroups(EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.)
- Incidence of skin reactions (Safety of StrokePointer)(EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.)
- Discriminative power of StrokePointer(EEG-data for analysis will be recorded within 24 hours after onset of symptoms or last seen well.)
研究者
Jonathan Coutinho
MD, PhD, neurologist, Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)