Induction of Therapeutic Hypothermia in the Pre-hospital Setting After the Return on Spontaneous Circulation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Induced therapeutic hypothermia in the pre-hospital setting improves outcomes
研究概览
简要总结
The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest.
详细描述
Induction of therapeutic hypothermia after return of spontaneous circulation (ROSC) in medical cardiac arrest is increasingly becoming the standard of care in the hospital setting. Several studies, including two sentinel research papers in the New England Journal of Medicine, show improved neurologic outcome with induced therapeutic hypothermia (ITH). 4, 5 This research led to a class IIa recommendation by the American Heart Association for ITH after ROSC in V-Fib arrest and a class IIb recommendation after ROSC in all other classes of medial cardiac arrest.6
The role of ITH in the pre-hospital setting is less clear. Studies currently exist that both show a benefit and fail to support improved outcomes.7-9 It has been suggested that the short transport times in most urban EMS systems might be part of the reason that some studies have failed to find benefit of ITH in the pre-hospital setting.
This is a prospective, randomized controlled trial involving all patients transported by CCEMS who have ROSC after a medical cardiac arrest and who are transported to a hospital that can continue ITH for 24 hours. All comatose patients who meet inclusion criteria will be randomized to either ITH in addition to continued treatment under standing protocols or regular care without ITH. Assignment to the two treatment arms will be done using the EMS number which is generated when the ambulance is dispatched to a call. Even numbered patients will have continued standard therapy while odd numbered patients will receive ITH.
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
- 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 patient transported by CCEMS with ROSC after a medical Cardiac Arrest to hospitals that can continue ITH
排除标准
- •Less than 18
- •Cardiac arrest due to trauma or hemorrhage
- •Pregnant women
- •patients whom are already hypothermic
- •transported to a hospital that can not maintain hypothermia for 24 hours
结局指标
主要结局
Induced therapeutic hypothermia in the pre-hospital setting improves outcomes
时间窗: followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated
Induced hypothermia and continued treatment under standing paramedic protocols. To determine if ITH in the pre-hospital setting improves outcomes at hospital discharge
次要结局
- Regular treatment without induced therapeutic hypothermia(followed until hospital discharge estimated to be from 2 days to 1 year if resuscitated)
研究者
Lori Weichenthal
Associate Residency Director, Wilderness Medicine Director
University of California, San Francisco
