A Randomized Controlled Trial on Early Double External Sequential Defibrillation in Out of Hospital Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 356
- 试验地点
- 2
- 主要终点
- Proportion of patients that survive to hospital admission.
研究概览
简要总结
Double Sequential External Defibrillation (DSED) represents an alternative treatment of refractory ventricular fibrillation (rVF) in out-of-hospital cardiac arrest (OHCA). The procedure consists of two defibrillators that administer shocks at the same time.
Currently, the procedure is not initiated before at least three failed attempts with one defibrillator. This can delay the potential benefits of establishing DSED earlier in the treatment. Studies have shown that early defibrillation is crucial for survival in OHCA patients, and in 2022, a clinical trial showed that survival in patients treated with DSED was higher compared to standard treatment.
The effect of initiating OHCA treatment is unknown. The DUALDEFIB trial seeks to investigate if treating OHCA patients with DSED as an initial treatment will increase survival and provide improved neurological outcome.
详细描述
The project is investigator-initiated, prospective, two-group randomized controlled trial (RCT). Prior to the RCT, a pilot feasibility trial of 3-4 months will be performed, including three ambulance bases in mid-Norway. All OHCA patients will be included until validity and feasibility of the study is accomplished. The pilot study will be followed by the RCT.
Outcome measurements in the RCT are aimed to be the same as in the pilot study. Ambulance bases will be randomized to either DSED or standard procedure for six months before crossover with the other treatment for six months.
Ambulances included in the project will carry two defibrillators. Both defibrillators will be established for initial defibrillation with DSED in OHCA patients. The pads are placed in anterior-lateral position (standard placement) and anterior-posterior position (over sternum and beneath left scapula). Shocks are administered in rapid succession with less than one second apart. All other treatment will be according to existing guidelines.
The included patients are OHCA patients with age over 18 years presenting with a shockable rhythm. Excluded patients are patients with obvious or suspected pregnancy, incarcerated patients or patients with no-resuscitation order. The patients that meet the inclusion criteria will be registered by the ambulance personnel through a secure webpage.
Primary outcome is survival to hospital admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients with out of hospital cardiac arrest presenting with a shockable rhythm
排除标准
- •Age below 18 years
- •Obvious or suspected pregnancy
- •Incarcerated patients
- •Preexisting do-not-resuscitate order
研究组 & 干预措施
Double sequential external defibrillation
Patient will receive first shock using two defibrillators. All other aspects of resuscitation in accordance to existing guidelines.
干预措施: Two defibrillators (Device)
Standard treatment
Standard treatment in accordance to existing Advanced Cardiopulmonary Resuscitation-guidelines using one defibrillator in anterior-lateral placement.
干预措施: One defibrillator (Device)
结局指标
主要结局
Proportion of patients that survive to hospital admission.
时间窗: 24 hours
Number of patients arriving with ROSC in hospital emergency facility.
次要结局
- Proportion of patients that survive for 30 days(30 days)
- Review of 30 day neurological status.(30 days)
- Proportion of patients that survive for 90 days(90 days)
- Review 90 day neurological status.(90 days)
- Proportion of patients that survive for one year.(365 days)