LUcas Continuous Chest Compressions in Out-of-hospital Cardiac Arrest Treatment. The LUCAT Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2)
研究概览
简要总结
The goal of this study is to show the superiority in survival at hospital admittance and in neurological outcome on hospital discharge of continuous mechanical chest compression using LUCAS device versus manual chest compressions in patients who suffered an out-of-hospital cardiac arrest.
详细描述
The primary goals of the trial are:
- To show a survival increase at hospital admittance after out-of-hospital cardiac arrest of patients treated by continuous chest compressions LUCAS device compared with patients treated by manual chest compressions.
- To evaluate neurological outcome on hospital discharge, in two centres (Vall d'Hebron Hospital and Josep Trueta Hospital).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: between 18 and 80 years ,
- •Suffering from NON traumatic or an unexpected SCA,
- •SCA witnessed (seen, heard or monitored),
- •Attended by an advanced support ambulance (served by doctor or nurse) in Barcelona city, or in the Girona or Lleida area
- •Time between alarm-call to SEM 061 and reaching patient is less than 12 minutes.
排除标准
- •Biological signs of death
- •Age under 18 or over 80 years
- •Trauma caused cardio respiratory arrest (CRA), including hanging
- •Secondary CRA or intoxication
- •Return of spontaneous circulation previous to arrival of SEM's medical team
- •Known pregnancy
- •Inadequate size for LUCAS device
- •Anything in the study that can delay treatment
研究组 & 干预措施
LUCAS, Continuous chest compressions
Mechanical continuous chest compressions performed by LUCAS device (also during defibrillation)
干预措施: LUCAS (Lund University Cardiac Assist Sysrem) (Device)
Manual chest compressions
Manual chest compression is performed, chest compressions halted during defibrillation
干预措施: Manual chest compressions (Other)
结局指标
主要结局
Survival on discharge from hospital (or 30 days if not applicable) in acceptable neurological state (CPC scale 1 or 2)
时间窗: 30 days
Evaluate the neurological outcome on hospital discharge, in two centres (Vall d'Hebron Hospital in Barcelona and Josep Trueta Hospital in Girona) 1 or 2 in Cerebral Performance Category
Survival at hospital admittance
时间窗: 2 hours
The primary goal is to evaluate survival at hospital admittance of patients, after out-of hospital cardiac arrest treated by LUCAS device chest compressions, compared with those patients treated by manual chest compressions
次要结局
- Restoration of spontaneous circulation(2 hours)
- EndTidal CO2 values(Every four minutes during resuscitation maneuvers)
- Left ventricular function(During the first 24h and during the 24h previous on hospital discharge or at two months)
- SOFA scale values(During the first three days and on hospital discharge)
- Epidemiology of Out-of-Hospital Cardiac Arrest(3 months)
- Days before discharge from Intensive Care Unit (ICU) / Coronary Care Unit (CCU)(30 days)
- Metabolic (pH, lactate) and inflamatory (leukocytes, C reactive protein) parameters(During the first 24h, at >48h and at 5-7days)
- To obtain a blood sample for genetic and biological studies(7 days)
研究者
Francesc Carmona Jimenez
Assistant Investigator
Sistema d'Emergències Mèdiques