Frontal EEG in Out-of-hospital Cardiac Arrest - a Prospective Observational Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Feasibility of BIS prehospital via quality parameters.
研究概览
简要总结
This study aims to optimize the treatment of out-of-hospital cardiac arrest (OHCA) by focusing on neurological outcomes through Bispectral Index (BIS) monitoring. It will evaluate the feasibility of BIS monitoring in the prehospital phase, assess the need for sedation based on BIS values, and examine the timing of interventions in ICU (intensive care unit) settings to identify irreversible Hypoxic-Ischemic Brain Injury (HIBI).
详细描述
The research project is designed to contribute to the low survival discharge rates of OHCA patients in Europe, which is currently around 8%.
Objectives:
- To assess the feasibility of BIS monitoring in the prehospital environment during CPR and ROSC.
- To determine the optimal mean BIS cut-off value after ROSC (Return of Spontaneous Circulation) during the prehospital phase.
- To assess BIS and etCO2 values in OHCA patients under evaluation of CPR quality.
- To understand the sedation needs based on BIS values.
- To identify the timing of interventions in the ICU that signify irreversible HIBI.
Phases:
- Phase 1: The initial focus is assessing BIS and etCO2 values in OHCA patients receiving CPR.
- Phase 2: We will investigate whether patients with higher mean BIS values (>25) require earlier and more sedation than those with lower BIS values.
- Phase 3: This phase will examine ICU interventions and their timing to ascertain which patients are at risk of suffering from irreversible HIBI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Age ≥18 years
- •In out-of-hospital cardiac arrest (OHCA)
排除标准
- •BIS application non-possible (for example, due to massive facial trauma)
- •No ALS (Advanced Life Support) performed
- •Clear signs of death
- •Sustained ROSC (>5 minutes after CPR with signs of life) on the arrival of the emergency physician
研究组 & 干预措施
Out-of-hospital cardiac arrest adult patients
All patients aged ≥18 years and in out-of-hospital cardiac arrest (OHCA) on arrival at the physician response unit (PRU) in Graz, Austria + surroundings.
干预措施: BIS Monitor (Device)
结局指标
主要结局
Feasibility of BIS prehospital via quality parameters.
时间窗: From PRU arrival until hand-over to the hospital (prehospital phase), on average 60 minutes.
To evaluate if frontal EEG (BIS) measurements are feasible and valid under CPR and at ROSC in the prehospital setting. The proportion of patients meeting the signal quality criteria in more than 75% of the measurement period (Signal quality index \>75, Electromyogram \<30) will be presented with a two-sided 95% confidence interval to assess the primary aim.
Feasibility of BIS prehospital via a questionnaire.
时间窗: Prehospital phase, on average 60 minutes.
The prehospital BIS feasibility will be assessed with a short questionnaire about the application and its handling.
次要结局
- Sedation at ROSC(Prehospital phase, on average 30 minutes.)
- ICU care(ICU stay, on average 4 days.)
- Prediction of neurological outcome.(Prehospital phase, on average 60 minutes.)
- CPR quality(Prehospital phase, on average 30 minutes.)