Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,114
- 试验地点
- 2
- 主要终点
- 30-day survival
研究概览
简要总结
The study will assess 30-day survival for cases where volunteer citizen responders ('heart runners') were activated through a smartphone app to retrieve an AED in case of suspected out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. The study will randomize emergency medical dispatch center incoming calls which are suspected out-of-hospital cardiac arrest, such that half will be randomized to activation of heart runners and half to no activation of heart runners (standard care). The study will also assess physical or psychological risks involved for the activated heart runners.
详细描述
Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from collapse until defibrillation. Activating volunteer citizens through the emergency medical dispatch center can potentially increase rates of bystander defibrillation and survival. The HeartRunner trial will investigage the effect of activating registered volunteer citizens through a mobile app integrated with the emergency medical services on 30-day survival following out-of-hospital cardiac arrest. Both arms will receive standard care by the Emergency Medical Services. The intervention arm will additionally receive the activation of volunteer citizen responders. The randomization will take place independently in 3 different strata according to heart runner distance to OHCA (< 3 min, 3-9 min, > 9 min). The trial will also assess whether it is safe, both physically and psychologically, to activate volunteer citizen responders to respond to out-of-hospital cardiac arrests.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and where the HeartRunner system is activated.
- •Non-traumatic etiology, this excludes intoxication, drowning or suicide.
- •Age > 7 years
排除标准
- •Caller is not in direct contact with the patient
- •If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes where trained personal is present.
- •OHCAs not treated by the EMS due to ethical reasons or obvious signs of death
- •OHCAs with no heart runners within 1800 meters
- •Not true cardiac arrest (suspected, but not verified)
- •EMS-witnessed OHCAs
- •Emergency medical dispatchers are instructed not to activate heart runners in case any of the exclusion criteria above. However, since it can be challenging for emergency medical dispatchers to gather sufficient information about the patient within the first few minutes, heart runners will admittedly be activated even though they should not have been. Since randomization will occur for all cases in which a heart runner is activated, cases with any of the exclusion criteria will be secondarily excluded.
- •These cases will be accounted for but not included in analyses of outcome. Our pilot study showed approximately 60% of suspected cardiac arrests were true cardiac arrests. Therefore, we expect 40% of cases for which heart runners were dispatched not to be true cardiac arrests.
研究组 & 干预措施
Usual Care (control arm)
These cardiac arrests will receive standard EMS response.
HeartRunner Activation
For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.
干预措施: Activation of HeartRunners (Other)
结局指标
主要结局
30-day survival
时间窗: 30 days after date of out-of-hospital cardiac arrest
Patient alive 30 days after date of out-of-hospital cardiac arrest
次要结局
- Rates of return of spontaneuous circulation(Immediately after out-of-hospital cardiac arrest)
- Rates of survival after 1 year(1 year after date of out-of-hospital cardiac arrest)
- Rates of bystander cardiopulmonary resuscitation(During cardiac arrest)
- Rates of neurological intact survival(At hospital discharge)
- Rates of bystander defibrillation(During cardiac arrest)
研究者
Fredrik Folke
MD, PhD, Head of Research
Emergency Medical Services, Capital Region, Denmark