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临床试验/NCT00609778
NCT00609778已完成不适用

A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation

Jolife AB6 个研究点 分布在 3 个国家目标入组 2,500 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Jolife AB
入组人数
2,500
试验地点
6
主要终点
Four hour survival from successful restoration of spontaneous circulation.

研究概览

简要总结

The primary objective is to show superiority in survival of the modified method with the LUCAS Chest Compression System, compared to the conventional manual resuscitation method in patients suffering from out of hospital sudden cardiac arrest.

详细描述

Every year 300 000 to 400 000 people suffer from sudden cardiac arrest outside of the hospital in Europe. Only 5 - 7 % of these patients survive and are discharged from hospital. In spite of massive education, research and new methods the survival rate has not improved. In the latest international guidelines for CPR, published in 2005, there is a strong emphasis on chest compressions with as little interruptions as possible. Manual chest compressions during CPR result in only 20-30% of normal blood flow and are difficult to perform for a long period of time. Mechanical chest compressions with the LUCAS device have shown increased blood flow in experimental studies. Defibrillation during ongoing mechanical compressions is a new method of treatment that showed promising results in increased short time survival in out of hospital cardiac arrest in a recently completed pilot study.

The LINC trial is a prospective randomised multicenter study where LUCAS according to a concept will be used with simultaneous defibrillation compared to manual chest compressions according to 2005 guidelines for advanced CPR. The study will be conducted in first tier systems, where LUCAS always will be placed in the first arriving ambulance.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unexpected adult out-of-hospital cardiac arrest where an attempt of resuscitation is considered appropriate.

排除标准

  • Traumatic cardiac arrest, including hanging
  • Age believed to be less than 18 years (no upper limit)
  • Known pregnancy
  • Defibrillated before LUCAS Chest Compressions System arrives at scene
  • Patients body size not fitting the LUCAS Chest Compression System

结局指标

主要结局

Four hour survival from successful restoration of spontaneous circulation.

时间窗: Four hours survival

次要结局

  • ROSC, Arrival to the emergency room with ROSC. Survival in hospital,Survival to hospital discharge Survival 1 and 6 months ( without severe neurological impairmen (CPC 1 or 2).(Restoration of ROSC, Arrival to emergency room with ROSC, Survival to discharge from ICU, Survival to hospital discharge, Survival one and six months after SCA)

研究者

发起方
Jolife AB
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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