A Multicenter Randomised Controlled Trial Comparing Shock Success With Synchronized Defibrillation (Compression Upstroke Versus Precompression) During Ongoing Mechanical Cardiopulmonary Resuscitation In The Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- successful electrical conversion (shock success)
研究概览
简要总结
In this study, we are comparing the difference in outcomes between patients who were given shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before CPR is started. The study population will be all cardiac arrest patients attended by the staff of the Emergency Department who fulfil the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest compressions are delivered by an automated device) is prepared. Mechanical CPR should be started as soon as possible (<1 minute). If patients are eligible to be shocked, they will receive shocks either during upstroke of CPR or before CPR is started.
Thus the purpose of this study is to answer the question whether are there improvement in survival between when shocks are given during upstroke and before CPR is started.
详细描述
The purpose of this study will be to compare shock success during defibrillation synchronized with the upstroke of chest compression (peak upstroke), and precompression (control). This will be the world's first study to characterize the phase dependency of defibrillation during mechanical CPR in humans and to evaluate if optimal synchronized defibrillation can improve clinical outcomes.
The null hypothesis would be that there is no difference in shock success during defibrillation synchronized with the upstroke of chest compression (peak upstroke), and precompression (control). We will conduct statistical comparisons for the primary and secondary outcomes between the arms of the study.
The study population will be all cardiac arrest patients attended by the staff of the ED over the study period who fulfill the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest with have manual chest compressions started while mechanical CPR is prepared. Mechanical CPR should be started as soon as possible (<1 minunte). If a shockable rhythm is present (VF/VT), patients will receive one of pre-randomized defibrillation protocols:
- Synchronised defibrillation at peak-upstroke
- Synchronised defibrillation at precompression
Definition of outcomes
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac Arrest patients who received eith CPR and/or defibrillation
- •Ventricular Fibrillation or Pulseless Ventricular Tachycardia
排除标准
- •Patients pronounced dead without attempting CPR according to standard operating procedure and ILCOR guidelines
- •Cardiac arrest obviously caused by major trauma
- •Children below age 21
- •Patients who are pregnant
研究组 & 干预措施
Upstroke Compression
Intervention arm
干预措施: Upstroke Compression Defibrillation (Device)
Precompression
Control arm
干预措施: Precompression Defibrillation (Device)
结局指标
主要结局
successful electrical conversion (shock success)
时间窗: establishment of organized rhythm within 60 seconds
Termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.
次要结局
- Survival to hospital admission(at least 1 day)
- Survival to hospital discharge(at least 1 day)
- Return of spontaneous circulation (ROSC)(at least 20 minutes)
- Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)(at least 1 day)
- termination of VF regardless of the resulting rhythm(at least 5 seconds after the shock)
- European Quality of Life in 5 Dimensions(at least 1 day)