AMplitude Spectrum Area to Guide Defibrillation During Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Return of spontaneous circulation (ROSC)
研究概览
简要总结
AMSA trial is a multicenter, randomized, controlled study in out-of-hospital cardiac arrest patients.
The purpose of the study is to test the hypothesis that a real time AMSA analysis during CPR may predict the success of defibrillation and optimize the timing of defibrillation delivery.
The primary end-point is the efficacy of the AMSA-CPR: termination of VF/VT with achievement of ROSC for an AMSA ≥ 15.5 mV-Hz
All patients meeting inclusion/exclusion criteria and receiving cardiopulmonary resuscitation are randomized into two groups: AMSA-guided CPR or standard CPR.
In the AMSA-CPR group, AMSA value suggests when the rescuer should deliver the defibrillation attempt; In the Standard-CPR group, the defibrillation is delivered based on the 2015 European Resuscitation Council (ERC) CPR guidelines.
详细描述
In the AMSA-CPR intervention, upon arrival of the advanced life support (ALS) rescue team at the cardiac arrest scene and application of the defibrillatory pads to the patient's chest and power on of the defibrillator with the real time AMSA analysis:
- If AMSA is ≥ 15.5 mV-Hz, an immediate defibrillation is attempted, followed by CPR
- If AMSA is < 15.5 mV-Hz, defibrillation is not attempted and CPR is delivered
- During the 2-min cycle of CPR, AMSA is measured during pauses for ventilations (every 30 CC, approximately every 20/25 sec). If an AMSA value ≥ 15.5 mV-Hz is achieved prior to cycle completion, an immediate defibrillation is delivered (thus the defibrillation attempt is anticipated)
After completion of the first 2-min CPR cycle:
- If AMSA is ≤ 6.5 mV-Hz, the defibrillation is not attempted but CPR is continued
- If AMSA is > 6.5 mV-Hz, an immediate defibrillation attempt is delivered, followed by CPR
- During the 2-min cycle of CPR, AMSA is measured during pauses for ventilations (every 30 CC, approximately every 20/25 sec). If an AMSA value ≥ 15.5 mV-Hz is achieved prior to cycle completion, an immediate defibrillation is delivered
After completion of the second 2-min CPR cycle and till the end of the resuscitative intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 adult patients (age ≥ 18) suffering of out-of-hospital non traumatic cardiac arrest of presumably cardiac etiology with a presenting shockable rhythm requiring electrical defibrillation: Ventricular Fibrillation and pulseless Ventricular Tachycardia.
排除标准
- •age < 18 years old
- •pregnancy
- •cardiac arrest with a non-shockable rhythm (pulseless electrical activity and asystole)
- •a defibrillation delivered by an AED prior to ALS arrival
- •cardiac arrest of traumatic origin
- •non-cardiac cause of cardiac arrest
- •presumable irreversible death or known terminal illness at the beginning of ALS
- •clinical death
- •participation in another clinical or device trial within the previous 30 days
- •refused informed consent to the use of data.
结局指标
主要结局
Return of spontaneous circulation (ROSC)
时间窗: At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first)
Termination of ventricular fibrillation with achievement of ROSC for an AMSA value ≥ 15.5 mV-Hz
次要结局
- CPR duration(At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first))
- Long term survival(at 1 and 6 months after ROSC)
- Cardiac troponins(at 6 and 24 hours after ICU admission)
- Defibrillation attempts(At day 0: from date of initiation of the cardiopulmonary resuscitation (CPR) maneuvres up to ROSC or up to 1 hour of CPR (which comes first))
- Short term survival(at hospital admission and 24 hours after ROSC)