EEG and SEP Evaluation for Good and Poor Neurological Prognosis After Cardiac Arrest: a Prospective Multicenter Cohort Trial (proNeCA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Cerebral Performance Categories
研究概览
简要总结
Hypoxic-Ischemic-encephalopathy (HIE) is a severe and frequent neurological complication of successful cardiopulmonary-resuscitation after cardiac arrest (CA). Prognosticating neurological outcomes in patients with HIE is challenging and recent guidelines suggest a multimodal approach. Only few studies have analyzed the prognostic power of the association between instrumental tests and, in addition, most of them were monocentric, retrospective and evaluating only poor outcome.
详细描述
Post-anoxic encephalopathy is a severe and frequent neurological complication of successful cardiopulmonary resuscitation and it is usually responsible for coma onset in patients surviving a CA. A reliable early assessment of the neurological prognosis is an important research goal because it could address CA patient management within intensive care units (ICUs).
However, prognosticating neurological outcomes in patients with HIE is challenging and recent guidelines suggest a multimodal approach. Only few studies have analyzed the prognostic power of the association between instrumental tests and, in addition, most of them were monocentric, retrospective and evaluating only poor outcome.
Thus, the investigators designed a multicenter prospective cohort study to assessing the prognostic power of the association of electroencephalogram(EEG) and somatosensory evoked potentials(SEPs) for the prediction of both poor and good neurological outcomes at different times after CA.
The principal aim of this study will be to evaluate the prognostic power of EEG performed in comatose patients within the first 12h after CA for good outcome prediction (cerebral performance categories CPC 1-2-3) and to evaluate its prognostic power for the poor outcome prediction (CPC 4-5) when performed at 24 and 72h after CA.
Moreover, the investigators will aim to evaluate if the combination of EEG and SEPs will allow to correctly identify a greater number of patients with both poor and good outcomes (when performed within the first 12h) and with poor outcomes (when performed after 72h) compared with the use of only a single test. In addition, the investigators will evaluate if the concordance of EEG/SEP patterns will increase the prognostic reliability obtained with a single test.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients between 18 and 90 years of age and
- •comatose patients surviving after CA with a Glasgow Coma Scale (GCS) <9
排除标准
- •patients with surgical or traumatic causes of CA,
- •patients showing contemporary presence of other neurological diseases (i.e. traumatic brain injury or brain infarction),
- •patients with previous severe neurological diseases,
- •patients with remote pathological anamnesis showing severe diseases with life expectancy less than 6 months,
- •patients with previous severe disability,
- •contemporary presence of confounding factors that hamper clinical evaluation (in particular the consciousness state)
- •patients with contemporary absence of cortical response N20/P25 and lemniscal wave P14
结局指标
主要结局
Cerebral Performance Categories
时间窗: Month 6
Neurological outcome will be the primary outcome measure and it will be assessed at 6 months after CA using CPC as follows: CPC 1, no or minor neurological deficits; CPC 2, moderate disability; CPC 3, severe disability; CPC 4, unresponsive wakefulness state and CPC 5, death. Neurological outcome will be dichotomized into 'good' (CPC 1-3) and 'poor' (CPC 4-5) outcomes
次要结局
- Electroencephalography, EEG(hour: 12-24-72)
- Somatosensory Evoked Potentials, SEP(hour: 12-24-72)
- Brain CT(within 24 hours)
研究者
Antonello Grippo
Grippo Antonello, MD
Azienda Ospedaliero-Universitaria Careggi