Evaluation of Early Prognosis Factors of Neurological Evolution After Resuscitated Cardiac Arrest in Adults
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Cerebral Performance Categories (CPC) score
研究概览
简要总结
Sudden cardiac arrest (CA) in adults remains a major public health issue in industrialized countries, leading to a mortality rate greater than 90%. The analysis of French data estimates the number of sudden deaths at around 40,000 per year. The incidence rate for non-hospital CAs is 55 per 100,000 every year with an immediate survival rate of 9% and 4.8% at one year.
详细描述
Approximately 80 % of patients who survive CA with cardiopulmonary resuscitation are comatose. The longer it lasts, the lower chances of recovery. The evaluation of the neurological prognosis of these patients is an important issue. Indeed, 72% of patients admitted to an intensive care unit after resuscitation from CA will give rise to an ethical discussion with the family. The prognostication strategy is usually based on a multimodal process involving clinical examination, electro-neurophysiological and biological examinations. We plan to study the relevance of early neurological prognostic tests in the aftermath of CA and in particular the most recent techniques such as the use of a clinical score (CAHP for Cardiac Arrest Hospital Prognosis), automated infrared pupillometry (NEUROLIGHT ALGISCAN, IDMED) for pupillary reflex measurement and quantitative analysis of the continuous amplitude-integrated electroencephalogram (aEEG) BRAIN QUICK ICU LINE, MICROMED. These new prognostic criteria for CA (CAHP score, pupillometry and aEEG) developed separately have not yet been integrated into a multimodal strategy.
The goal of this study is to evaluate the performance of CAHP score, infrared automated pupillometry and aEEG to predict as early as 24h from ROSC the neurological prognosis (Cerebral Performance Categories) at hospital discharge.
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
- •Admission in Intensive Care Unit (ICU) following cardiac arrest with ROSC
排除标准
- •Minor patient
- •Cardiac arrest (CA) occuring in ICU
- •Decision before ICU admission to withdraw life-sustaining treatments
- •Patient with post-ROSC Glasgow Coma Score = 15
结局指标
主要结局
Cerebral Performance Categories (CPC) score
时间窗: Day 1
The Cerebral Performance Categories (CPC) score is evaluated by a physician at hospital discharge (CPC baseline assessed on basal statut before CA). Good neurological outcome defined as CPC \<3. CPC 1: no or minor disability (conscious and independent, able to work and lead a normal life. May have mild dysphasia, non-incapacitating hemiparesis, or minor cranial nerve abnormalities). CPC 2: Moderate disability (Conscious and independent, able to travel by public transport and work in sheltered environment, independent in activities of daily life. May have hemiplegia, seizures, ataxia, dysarthria or memory changes). Poor neurological outcome defined as CPC 3-5. CPC 3: severe disability (conscious but dependent, limited cognition, dementia, locked-in, minimally conscious. Usually in institution, but sometimes looked after at home with exceptional family effort). CPC 4: unconscious (persistent vegetative state). CPC 5: dead (certified brain dead or traditional criteria).
次要结局
- Cardiac Arrest Hospital Prognosis (CAHP) Score(Day 1)
- Neuron Specific Enolase (NSE) plasmatic levels(Day 3)
- Pupillary light reflex surveillance with automated infrared pupillometry(Day 1)
- Amplitude-integrated electroencephalography (aEEG)(Day 1)