Feasibility Study on a Prehospital Extracorporeal CardioPulmonary Resuscitation in the Pavia's Province. An Interventional Study on Complex Treatment Strategy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria
研究概览
简要总结
This is a single Center interventional study, assessing the feasibility of a complex treatment strategy where an in-hospital standard care process is applied in an out-of-hospital cardiac arrest.
The objective of this study is to investigate the feasibility of a prehospital eCPR program in the context of the Pavia province in order to reduce the time from cardiac arrest to organ reperfusion with thefarthest aim of improving survival and good neurologic outcomes of patient victims of refractory cardiac arrest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •out-of-hospital cardiac arrest occurred in Pavia province
- •the age of the patient is between 18 and 70
- •witnessed cardiac arrest
- •CPR started within 5 minutes of the patient's collapse or presence of gasping at the arrival of the ACLS team
- •eCPR team arrived within 60 minutes of the patient's collapse
- •etCO2 ≥ 10 mmHg
- •mechanical chest compression is ongoing
- •refractory cardiac arrest after at least 15 minutes of ACLS
排除标准
- •Modified Rankin Scale (mRS) ≥ 3
- •Advanced COPD or other advanced pulmonary illness
- •End-stage or metastatic neoplasm
结局指标
主要结局
number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria
时间窗: up to 12 months
Successful cannulation is described as maintaining an ECMO circulatory flow of 40 ml/kg/min or more for at least 5 minutes.
number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria
时间窗: up to 12 months
Successful cannulation is described as maintaining an ECMO circulatory flow of 40 ml/kg/min or more for at least 5 minutes.
次要结局
- Cause of cannulation failure(up to 12 months)
- Evaluation of eCPR Team Performance(up to 12 months)
- Cause of cannulation failure(up to 12 months)
- Proportion of cannulation feasibility according to the implant site(up to 12 months)
- Evaluation of eCPR Team Performance(up to 12 months)
研究者
Alessandra Palo
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia