Pre-Hospital Cooling in Cardiac Arrest Patients - Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Effectivity measure - reached cooling rate calculated in °C/30 min
研究概览
简要总结
Type of study: Pilot prospective nonrandomized feasibility clinical study.
Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in patients successfully resuscitated from out-of-hospital cardiac arrest in the setting of prehospital and hospital care in Czech republic.
Evaluated hypothesis: Pre-hospital initiation of therapeutic mild hypothermia by rapid administration of intravenous bolus of cold crystalloids is simple, safe, effective and is a feasible procedure to significantly decrease body core temperature during patient's transport to the hospital in Czech republic.
The study is observational and does not evaluate any new drug, therapeutic procedure or diagnostic procedure. It is evaluating a known therapeutic procedure, therapeutic mild hypothermia, induced by known technique, cold crystalloid infusion, widely accepted in hospital-related postresuscitative care. However, even its prehospital usage has been published.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients resuscitated from out-of-hospital cardiac arrest
- •remaining comatose and requiring mechanical ventilation
排除标准
- •cardiac arrest of traumatic etiology
- •patient conscious after short cardiopulmonary resuscitation
- •coma of other origin than cardiac arrest (e.g., epileptic paroxysm, intoxication etc.)
- •severe acute heart failure
- •accidental hypothermia below 30°C
- •bradycardia requiring transcutaneous cardiac pacing
- •status Do Not Resuscitate or Do Not Intubate
- •severe circulatory shock
- •severe life threatening cardiac arrhythmias
- •severe and life threatening bleeding
- •severe sepsis
- •any common opinion of intervening team of unfitness of induction of therapeutic mild hypothermia
结局指标
主要结局
Effectivity measure - reached cooling rate calculated in °C/30 min
时间窗: Assessed during prehospital phase
次要结局
- Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia(Assessed during prehospital phase)
- Achievement of favourable neurological outcome at the hospital discharge(Assessed during prehospital and in-hospital phase)
- Overall prehospital and in-hospital mortality(Assessed during prehospital and in-hospital phase)
- The best neurological outcome achieved anytime during hospital stay(Assessed during in-hospital phase)