A Randomized Trial Comparing the Effect of a Simplified Form of Cardiopulmonary Resuscitation (CPR) Consisting of Only Chest Compressions Compared to CPR With Compressions and Rescue Breaths - the PILOT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Descriptive measurement of feasibility
研究概览
简要总结
Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of mortality in the industrialized world. Bystander CPR before arrival of the Emergency Medical Service (EMS) is a positive predictor of survival. During the last decade, the best form of bystander CPR has been debated. Chest Compression Only CPR (CO-CPR) has been advocated as a preferable method in situations where the bystander has no previous knowledge in CPR, both because its believed to be equally efficient but also a simplified form of CPR that could lead to a higher incidence of bystander-CPR.
The purpose of this study is to perform av run-in period with focus on safety and feasibility prior to the launch of a larger randomized trial which has a primary end-point of survival. This study will compare OHCA with standard CPR (S-CPR; chest compressions and rescue breaths in a 30:2 fashion) compared to CO-CPR.
详细描述
Witnessed cases of OHCA with a non-asphyctic aetiology will be the principal study population. According to current guidelines an unresponsive patient with no or agonal breathing is treated as a suspected case of OHCA at the dispatch centre. These cases are eligible for screening for inclusion. If the case is witnessed, the bystander has previous knowledge in CPR and no exclusion criteria are present, the case can be included in the study.
The intervention consists of instructions from a dispatcher at the dispatch centre to bystanders to perform either CO-CPR (intervention) or S-CPR (control).
Instructions to bystanders on how to perform CO-CPR consists of continuous chest compressions without interruptions or rescue breaths. The instructions on how to perform S-CPR in the control group include information on giving chest compressions and rescue breaths in a 30:2 ratio (like current CPR recommendation state).
This is a national study were all dispatch centers in Sweden participate.
The overall study project is conducted in three different phases:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unconsciousness with no, abnormal or agonal breathing (suspected OHCA)
- •The suspected OHCA is witnessed (seen or heard)
- •Bystander has previous training in CPR
排除标准
- •Age 18 or younger
- •Collapse is not witnessed
- •Bystander has never been trained in CPR (these bystanders should be instructed to administer CO-CPR in accordance to guidelines).
- •Obvious asphyxia, i.e. drowning, strangulation, hanging
- •Obvious intoxication or drug overdose
- •Pregnancy
- •Obvious pregnancy
- •Bystander is unwilling to participate or to perform CPR
研究组 & 干预措施
CO-CPR Bystander
Instructions by dispatcher to trained bystander to provide CPR with chest-compressions only
干预措施: CO-CPR (Procedure)
S-CPR Bystander
Instructions by dispatcher to trained bystander to provide CPR with chest-compressions and rescue breaths in a 30:2 ratio
干预措施: S-CPR (Procedure)
结局指标
主要结局
Descriptive measurement of feasibility
时间窗: 6 months
* Evaluation of automated inclusion and randomization * Evaluation of information of allocation to bystander * Adherence to the two protocol, bystanders (S-CPR/CO-CPR) * Validation of data collection and sources (please see appendix) * Sufficient inclusion of all OHCA during the RUN-IN study period
Descriptive measurement of safety (delay CPR)
时间窗: 6 months
* Delay to start of CPR due to screening for inclusion, exclusion, randomization and instructions to the witnesses (S-CPR/CO-CPR) * Correct inclusion * Correct exclusion * Proportion of patients correctly identified as cardiac arrests
次要结局
- Proportions of patients with ventricular fibrillation/ ventricular tachycardia (ITT and PP)(within minutes from arrival of the EMS (day 1))
- Proportion of patients who achieve return of spontaneous circulation (ROSC)(day 1)
- Survival to hospital admission(day 1)
研究者
Jacob Hollenberg
MD, PhD
Karolinska Institutet