Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest (TOMCAT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Value of ONSD for short-term mortality prediction
研究概览
简要总结
In sudden cardiac arrest patients with return of spontaneous circulation, brain damage is one of the main determinants of short-term mortality and poor prognosis (CPC 3-5). It is important to properly select group of patients in whom treatment is futile. According to current guidelines, multimodal approach is recommended. Optic nerve sheath diameter measured by ultrasound is non-invasive, fast, low-cost and readily available bed-side method, but evidence for its use as neuroprognostication modality is limited to only few small studies. The aim of this study is to evaluate validity of ONSD as neuroprognostication method at larger cohort of patients, compare it with other established methods and compare ultrasound and CT measurement of ONSD.
详细描述
Additional relevant MeSH terms:
cardiac arrest, cardiovascular diseases, optic nerve sheath diameter.
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
- •age of 18 years or older
- •out of hospital cardiac arrest of non-traumatic cause with CPR and subsequent ROSC
- •Glasgow coma scale (GCS) ≤ 7 or sedation 30 minutes after ROSC achievment
排除标准
- •unavailable first measurment of the optic nerve sheath diameter (ONSD) measured by transorbital ultrasonography 24±6 hours after ROSC achievement
- •refractory cardiac arrest
- •craniocerebral injury
- •intracranial tumor
- •active intracranial bleeding
- •haemorrhagic stroke and/or subarachnoid haemorrhage in the last 3 months
- •facial trauma affecting the eye area
- •active neuroendocrine tumor, small cell lung cancer, non-small cell lung
- •CPC 3-5 before cardiac arrest
- •sclerosis multiplex and/or optic neuritis of other etiology
结局指标
主要结局
Value of ONSD for short-term mortality prediction
时间窗: 30 days
Assessment of the correlation between optic nerve sheath diameter measured by transorbital ultrasonography and mortality during a 30-day follow-up.
Value of ONSD for short-term neurological outcome prediction
时间窗: 30 days
Assessment of the correlation between the optic nerve sheath diameter measured by transorbital ultrasonography and neurological outcome of patients (quantified by the CPC scale) after out of hospital cardiac arrest with subsequent ROSC
次要结局
- Comparison of ONSD measurements by ultrasonography and computed tomography(48 hours)
- Comparison of ONSD and electrophysiologic modalities for neurological outcome prediction(96 hours)
- Value of ONSD for long-term neurological outcome and mortality(6 months)
- Correlation between ONSD and fundoscopic signs of papillary edema(48 hours)
- Effect of blood carbon dioxide on ONSD(72 hours)
- Correlation between ONSD and thickness of retinal nerve fibers measured by OCT(5 months)
- Correlation between blood NSE, copeptin and selected RNAs(6 months)