SNPeCPR Pour la prIse en Charge Des Arrêts CaRdiaques Extrahospitaliers
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of return of spontaneous circulation (ROSC)
研究概览
简要总结
Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic resuscitation survival after cardiac arrest remains low (1-8%) and has not changed significantly over the past five decades.It has recently been shown that the combination of different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with automated compression / decompression and an impedance threshold device, can increase the rate of return of spontaneous circulation and short and long term survival after cardiac arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold deviceb) a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of spontaneous circulation rate during cardiac arrest.
详细描述
- OBJECTIVES The objective of this study is to demonstrate the superiority of Sodium nitroprusside enhanced cardiopulmonary resuscitation (SNPeCPR) on optimized standard cardiopulmonary resuscitation.
SNPeCPR includes two components:
- a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold device
- a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decreasing vascular resistance, facilitates flow elevation in vital organs.
1.1. Main Objective : Assess the interests of the administration of sodium nitroprusside during enhanced cardiopulmonary resuscitation.
1.2. Secondary Objectives : To evaluate the effect of sodium nitroprusside on various parameters before and after the return of spontaneous circulation.
1.3. Outcome Measures : In this declaration, all the criterions measures before ROSC have been note as t=0 minute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with out of hospital cardiac arrest
- •Age> 18 years and <75 years
- •Initial Rhythm: Ventricular fibrillation or ventricular tachycardia or pulseless electrical activity
排除标准
- •out of hospital cardiac arrest of non-cardiac origin:
- •anoxic, including drowning
- •hemorrhage,
- •overdose (drugs),
- •Do Not Resuscitate Order,
- •obvious signs of clinical death (decomposition, cadaveric rigidity, decapitation)
- •recent sternotomy (<6 months or recent scar)
- •Contraindications related to sodium nitroprusside
- •Women of childbearing age (between 18 and 55 years)
- •Other contra-indications will usually not known during resuscitation in case of presence of a relative rescue team must be searched: Hypothyroidism, Sulfuryl transferase deficiency (rhodanese Lang) currently recognized in patients with Leber optic atrophy, tobacco amblyopia or severe hepatic impairment.
结局指标
主要结局
Rate of return of spontaneous circulation (ROSC)
时间窗: at 5 minutes
Rate of return of spontaneous circulation (ROSC) defined as a central pulse (carotid or femoral) palpable for more than 5 minutes
次要结局
- SpO2(at 0, 5 and 60 minutes)
- Creatinine(at 24 hours)
- Liver function(at 24 hours)
- Blood pressure(at 5 and 60 min)
- ECG(at 0, 5 and 60 minutes)
- Troponin(at 24 hours)
- Echocardiography(at 4 and 24 hours)
- ETCO2(at 0, 5 and 60 minutes)
- Neurological score(1 week, 2 weeks, 1 and 6 months)
- Arterial blood gases with lactate(at 0 and 5 minutes; 1, 4 and 24 hours)
- Survival(1, 4 and 24 hours, 1 week, 2 weeks, 1 and 6 months)