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临床试验/NCT01745926
NCT01745926已完成不适用

Implementation of LUCAS 2 in Helicopter Rescue in South Tyrol

Institute of Mountain Emergency Medicine1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年4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
入组人数
18
试验地点
1
主要终点
Time from arrival of rescue team to start of mechanical compressions

研究概览

简要总结

Cardiopulmonary resuscitation (CPR) is used to maintain adequate perfusion of vital organs in cardiac arrest patients and is fundamental for the neurological outcome and survival of these individuals. Unfortunately, the quality of CPR may be inadequate due largely to ineffective chest compressions resulting from rescuer fatigue and interruptions in compressions. The LUCAS device (Lund University Cardiopulmonary Assist System, Jolife, Lund, Sweden), introduced in 2002, is the most extensively tested and applied automated alternative to manual CPR for in-hospital care of cardiac arrest patients and during ambulance transfer; the feasibility of application of this device in helicopter emergency medical service (HEMS) operations, however, has never been addressed. The objective of this project is to equip the three active rescue helicopters in South Tyrol with the LUCAS 2 mechanical chest compression device to answer the question: What is the feasibility and efficiency of using this device for prolonged CPR in cardiac arrest patients requiring CPR during HEMS rescue operations and transport?

详细描述

This is a non-controlled, observational study. Physiological endpoints: MAP (mean arterial pressure); etCO2 (end-tidal expiratory pCO2); ROSC (return of spontaneous circulation); PaO2 (arterial pO2); PaCO2 (arterial pCO2); endpoints to assess feasibility: time from arrival to start of mechanical compressions, problems during transfer into the helicopter and in-field manoeuvers, problems with application of device, problems with patient transfer to hospital premises, hands-off time, personnel requirements.

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

入选标准

  • cardiac arrest with indication of CPR
  • informed consent for those regaining legal competence

排除标准

  • declaration of death on site
  • contraindications of using the device
  • age <18 y

结局指标

主要结局

Time from arrival of rescue team to start of mechanical compressions

时间窗: assessed immediatly after the operation is concluded

Presence of abdominal or thoracic lesions caused by automated chest compressor

时间窗: Assessed at clinical examination during hospital stay (day 1 to day 30) or autopsy

次要结局

  • End-tidal expiratory pCO2(At hospital arrival (expected between 5 minutes and 1 hour from start CPR))
  • Arterial pCO2(At hospital arrival (expected between 5 minutes and 1 hour from start CPR))
  • Mean arterial pressure(At hospital arrival (expected between 5 minutes and 1 hour from start CPR))
  • Return of spontaneous circulation(Could be each moment during CPR)
  • Arterial pO2(At hospital arrival (expected between 5 minutes and 1 hour from start CPR))

研究者

发起方
Institute of Mountain Emergency Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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