A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Successful Conversion to an Organized Heart Rhythm
研究概览
简要总结
This study will compare the effect of constant low-level energy [150 joules] to an escalating energy [200-300-360 joules] regimen of biphasic waveform defibrillation on multiple patient outcomes.
详细描述
This pilot, which will enroll 200 subjects, will allow a reasonable estimate of effect size and this will, in turn, allow for the accurate design and planning of a definitive randomized controlled trial. The following outcomes will be evaluated:
- Important Clinical Outcomes:
- Successful conversion,
- Resuscitation to one hour,
- Survival to hospital discharge,
- Neurological function, and
- Quality of life.
- Process Outcomes:
- Number of shocks required,
- Recurrences of VF, and
- Responsiveness to varying periods of pulselessness.
- Adverse Outcomes:
- Myocardial damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator
排除标准
- •Terminal illness or do-not-resuscitate (DNR) status
- •No cardiopulmonary resuscitation (CPR) x 10 minutes
- •Acute trauma
- •Exsanguination
- •Cardiac arrest experienced while in hospital
研究组 & 干预措施
Fixed lower-energy
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
干预措施: Fixed lower-energy defibrillation (Procedure)
Escalating higher-Energy
Out-of-hospital cardiac arrest patients undergoing defibrillation received an escalating higher-energy regimen beginning with 200 J, proceeding to 300 J for the second shock and 360 J for all remaining shocks
干预措施: Escalating higher-energy defibrillation (Procedure)
结局指标
主要结局
Successful Conversion to an Organized Heart Rhythm
时间窗: Termination of defibrillation
次要结局
- Survival to Hospital Discharge(30 days)
- Resuscitation for Survival to One Hour(One hour from termination of defibrillation)
- Neurologic Function(30 days)
- Return of Spontaneous Circulation(Termination of defibrillation)
- Survival to 24 Hours(24 hours)