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临床试验/NCT04080986
NCT04080986已完成不适用

DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSEVF) Randomized Controlled Trial

Sunnybrook Health Sciences Centre6 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2019年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
405
试验地点
6
主要终点
Survival to Hospital Discharge

研究概览

简要总结

Despite significant advances in resuscitation efforts, there are some patients who remain in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double sequential external defibrillation (DSED) and vector change defibrillation have been proposed as viable options for patients in refractory VF. This cluster randomized trial will compare (1) continued resuscitation using standard defibrillation; (2) resuscitation involving DSED; or (3) resuscitation involving vector change defibrillation, in patients presenting with refractory VF during out-of-hospital cardiac arrest. The results of this study will provide high level evidence of the impact of both DSED and vector change defibrillation on ROSC and patient survival after OHCA.

详细描述

Double sequential external defibrillation (DSED) and vector change defibrillation have been proposed as viable options for patients in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. However, currently there is insufficient evidence to support widespread implementation of this therapy. As such, a well-designed randomized controlled trial (RCT) employing a standardized approach to alternative defibrillation strategies early in the treatment of refractory VF is required to determine whether these treatments may impact clinical outcomes. This cluster randomized trial will be conducted in the regions of Peel, Halton, Simcoe, and the cities of London, Ottawa, and Toronto, Ontario, Canada over a three year time period. All adult (≥ 18 years) patients presenting in refractory VF/pulseless ventricular tachycardia (pVT) (defined as patients presenting in VF/pVT and remaining in VF/pVT after three consecutive standard defibrillation attempts each separated by 2 minutes of CPR) during out-of-hospital cardiac arrest of presumed cardiac etiology will be assigned to be treated by one of three strategies: (1) continued resuscitation using standard defibrillation; (2) resuscitation involving DSED (two defibrillators, one using anterior-posterior pad placement and the second using anterior- anterior pad placement delivering two rapid sequential shocks for all subsequent defibrillation attempts); or (3) resuscitation involving vector change (change of defibrillation pads from anterior-anterior to an anterior-posterior pad position) defibrillation. All study arms will continue to receive antiarrhythmic use and epinephrine as per current provincial standards. The cluster units will be defined by emergency medical service (EMS) agency and each cluster will crossover at 6 month intervals throughout the duration of the study.

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

  • •≥ 18 years of age
  • •Non-traumatic cardiac arrest of presumed cardiac etiology
  • •Presenting rhythm of ventricular fibrillation or pulseless ventricular tachycardia
  • •No ROSC or non-shockable rhythm after three consecutive shocks by EMS or fire department.

排除标准

  • •Traumatic cardiac arrest
  • •Patients with pre-existing do not resuscitate orders
  • •Patients without VF or pulseless VT as presenting rhythm
  • •Patients without three consecutive shocks delivered
  • •Patients initially treated by non-participating fire or EMS agencies.

研究组 & 干预措施

Standard Arm

No Intervention

All defibrillation attempts will occur using the standard defibrillation method, i.e. defibrillation pads will be placed in the anterior-anterior configuration. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.

Double Sequential Defibrillation

Active Comparator

The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. For all further shocks, a second set of defibrillation pads (via a second on scene EMS or fire defibrillator) will be applied in the anterior-posterior position, and defibrillation will be carried out by sequential defibrillation shocks provided by the two defibrillators (i.e. with a short delay between the two defibrillators). The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.

干预措施: Double Sequential Defibrillation (Procedure)

Vector Change Defibrillation

Active Comparator

The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. All further shocks will occur with the pads placed in the anterior-posterior position. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.

干预措施: Vector Change Defibrillation (Procedure)

结局指标

主要结局

Survival to Hospital Discharge

时间窗: Through study completion of three years

Binary outcome of whether the patient was discharged alive from hospital or died prior to discharge.

次要结局

  • Neurologic outcome(Throughout study completion of three years)
  • Return of Spontaneous Circulation(1 Day)
  • VF termination after first interventional shock(1 Day)
  • VF Termination after all interventional shocks(1 Day)
  • Number of defibrillation attempts to achieve Return of spontaneous circulation(1 Day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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