Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,586
- 试验地点
- 3
- 主要终点
- Rate of ROSC During the Prehospital Resuscitation
研究概览
简要总结
The purpose of this study is to evaluate whether or not real-time feedback on CPR process variables will increase rates of restoration of spontaneous circulation during prehospital resuscitation and upon arrival at the receiving emergency room as well as increase rates of survival to hospital discharge.
详细描述
A subset of emergency medical services (EMS) agencies that are participating in the Resuscitation Outcomes Consortium (ROC) are adopting new monitor/defibrillators that are capable of monitoring CPR process during attempted resuscitation of patients in cardiac arrest, as well as providing automated real-time feedback about this process to EMS providers so as to improve compliance with recommended guidelines for CPR. Monitoring of CPR process during attempted resuscitation is an important step towards reducing the potential for poorly-performed CPR to modify the effect of the study interventions upon outcome. Clusters formed of rigs, an individual agency or groups of agencies were randomized to turn feedback on or off. After a fixed period of time, each cluster crossed over to the other arm. An unequal number of subjects were enrolled during each period.
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
- •all individuals who experience cardiac arrest outside the hospital,
- •are evaluated by organized EMS personnel and: a) receive attempts at external defibrillation (by lay responders or emergency personnel) or receive chest compressions by organized EMS personnel.
排除标准
- •Use of a mechanical CPR device
研究组 & 干预措施
Feedback On
Automated real-time feedback on CPR Process activated
干预措施: Laerdal Q-CPR /technology (Other)
Feedback Off
For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
结局指标
主要结局
Rate of ROSC During the Prehospital Resuscitation
时间窗: Prehospital resuscitation
Return of spontaneous circulation (ROSC)
次要结局
- Pulses Present at ED Arrival.(Resuscitation)
- Compression Rate(Up to 10 minutes of CPR)
- Percentage of Compressions With an Incomplete Release(Up to 10 minutes of CPR)
- Ventilation Rate(Up to 10 minutes of CPR)
- Survival to Hospital Discharge(Length of Hospitalization)
- CPR Fraction(Up to 10 minutes of CPR)
- Compression Depth(Up to 10 minutes of CPR)
研究者
Susanne May
Professor
University of Washington