EASY CARE Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Return of spontaneous circulation (ROSC) prediction
研究概览
简要总结
Easy Care study wants to demonstrate a correlation between intra-CPR infrared quantitative pupillometry and return of spontaneous circulation (ROSC).
Neurological pupil index (NPi) will be used alone and in association with end-tidal CO2.
详细描述
At the arrival of medicalised rescue team on the emergency scene, patient will be screened for including criteria. In case of eligibility pupillometry will be collected each eye in the following frame time:
- T 0: time of enrolling
- T 1: after first cycle of resuscitation (approximatively 2 minutes following guidelines)
- T 2 ... Tn: every cycle of CPR (or every 2 minutes if intubated patient) bilateral pupillometry will be collected
- T end: the last pupillometry at ROSC time or death. All pupillometry mesures will be obtained from a technician not trained to interpret NPi index. This to maintain blindness during resuscitation efforts.
Data will be collected in anonymous web-based database passwords protected. For the survivors patients enrolled, data collecting continue in Intensive Care Unit (ICU) as neuroprognostication exams (biomarkers, imaging, neurophysiology). Blind follow up will be obtained from ICU as described in secondary outcome section
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
- •Not traumatic cardiac arrest in pre-hospital setting (OHCA)
- •unexpected OHCA
- •Lombardy region territory
排除标准
- •Traumatic Brain injury
- •Cerebrovascular emergecies at computer tomography (CT) scan after hospital admission
- •Peripheral or cortical blindness
- •One or both eyes loss
- •Iris palsy or known peripheral anisocoria
- •No indication for resuscitation
结局指标
主要结局
Return of spontaneous circulation (ROSC) prediction
时间窗: Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes
We are searching for possible correlation between pupillary reactivity (NPi) collected during resuscitation manoeuvres and ROSC. NPi is a numeric score ranges from 0 (unreactive pupils) and 5 (normal reflex).
次要结局
- Correlation between NPi trend and ROSC(Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes)
- Correlation of NPi and end tidal CO2 (ETCO2) and ROSC prediction(Variable because depends on the cardiac resuscitation manoeuvers lasting usually not more than 45 minutes)
- Correlation between NPi and Neurological Outcome as Modified Rankin Scale (mRS)(1 month, 6 months, 1 year)
- Correlation between NPi trend and mRS in ROSC patients(1 month, 6 months, 1 year)
研究者
Simone Maria Zerbi
Principal Investigator
Azienda Ospedaliera Sant'Anna