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临床试验/NCT02527694
NCT02527694已完成不适用

Comparison of Quality of Cardiopulmonary Resuscitation Between Flexible Stretcher and Standard Stretcher in Out-of-Hospital Cardiac Arrest: Ambulance Stretcher Innovation of Asian CPR (ASIA-CPR) Trial

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups

研究概览

简要总结

This study aims to compare the quality of emergency medical services cardiopulmonary resuscitation between flexible stretcher and standard stretcher during ambulance transport to hospital among out-of-hospital cardiac arrest patients.

详细描述

Background: Cardiopulmonary resuscitation (CPR) during ambulance transport in Asia has been known to be ineffective for quality and unsafe for emergency medical services(EMS)providers. Small elevators in high rise buildings are the most serious barriers to provide high quality CPR due to too long stretcher cart to enter in the elevators. We developed flexible stretcher cart to be safely used in small elevator through reducing the length of the stretcher. This study aims to compare the quality of EMS CPR between flexible stretcher and standard stretcher during transport to hospital.

Method:

This is a before and after-trial in a metropolis EMS. Study targets are adult out-of-hospital cardiac arrest (OHCA), excluding evident death cases, pregnancy, DNR cases, and too big or too small body size for stretcher cart or mechanical CPR devices. In the before period, the standard stretcher will be used for manual CPR using standard CPR protocol. In the after period, the flexible stretcher will be used with mechanical CPR devices after 3 cycles of standard manual CPR. Individual and Utstein risk factors will be collected. Main outcomes are no-flow fraction (NFF) measured by defibrillators (X-series) and safety will be measured on mechanical error, transportation error, patient injury and EMS provider injury. Sample size were 24 cases for before (12 cases) and after (12 cases) trial from 80% power and 0.05 of alpha error for expecting 20% quality difference (30% NFF inflexible stretcher and 50% NFF in standard stretcher)

Expected impact:

The study will be expected to find the benefit of flexible stretcher cart during CPR in small elevators. This findings will contribute to revise the Asian EMS protocol for improving quality of CPR.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All EMS-assessed OHCA in (3-4) selected districts in Seoul
  • 18 years or older of age

排除标准

  • Do-Not-Resuscitation cases or OHCA occurring in result of terminal diseases
  • Signs of evident death (decapitation, evident livor mortis or rigor mortis)
  • Physique too large for mechanical CPR device application
  • Chest deformation or injury
  • EMS CPR quality not assessed by the defibrillator
  • Return of spontaneous circulation (ROSC) before scene departure
  • Cardiac arrest cases during transport

研究组 & 干预措施

Flexible EMS Stretcher Cart Group

Experimental

Patients in this group will be transported on the new flexible EMS stretcher cart and receive mechanical CPR during transport to the hospital. The intervention will be given during elevator transport (if applicable) as well as in the moving ambulance.

干预措施: Flexible EMS stretcher cart (Device)

Flexible EMS Stretcher Cart Group

Experimental

Patients in this group will be transported on the new flexible EMS stretcher cart and receive mechanical CPR during transport to the hospital. The intervention will be given during elevator transport (if applicable) as well as in the moving ambulance.

干预措施: mechanical CPR (Device)

Standard Stretcher Cart Group

No Intervention

Patients in this group will be transported on the standard stretcher cart and receive manual CPR during transport to the hospital. The resuscitation protocol will follow the current standard protocol used by the EMS providers.

结局指标

主要结局

Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups

时间窗: During the total prehospital resuscitation time

Chest compression fraction was calculated as proportion of CPR time spent providing compressions.

次要结局

  • CPR Duration(During total prehospital resuscitation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sang Do Shin

Associate Professor

Seoul National University Hospital

研究点 (2)

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