Randomised comparison of chest compression using the device AutoPulse® with manual chest compressions in patients requiring Cardiopulmonary Resuscitation (CPR) for in hospital cardiac arrest.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoints:
研究概览
简要总结
Continuous chestcompressions are an important and indispensable part of cardiopulmonaryresuscitation (CPR) and has been shown to enhance survival. However the quality of the chest compressions provided by the rescueris often variable and not only depends on the physical built of the rescuer butalso on the positioning of the patient. Also the quality of the chest compressions decline with increasingtime of CPR, often requiring change of rescuer every 2 minutes. The AutoPulse® Resuscitation System (ZOLL Circulation) is a batteryoperated load distributing band (LDB) circumferential chest compression device. AutoPulse® provides mechanical chest compressions utilizing an electricallyactuated constricting band on a short backboard. Although it has been mentionedin the CPR 2010 guidelines, but data regarding its usefulness in CPR is still equivocal. Therefore we propose an investigator initiated randomised comparisonof mechanically assisted CPR using AutoPulse® (A-CPR) with conventional CPRinvolving manual chest compressions (M-CPR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with cardiac arrest in emergency department.
排除标准
- •1.Age < 18 years.
- •2.Cardiac arrest patients with chest trauma.
- •3.Patient already on Advanced life Support 4.Patients achieving ROSC after the initial 5 mins of manual CPR according to the 2010 guidelines.
- •5.Predicted Futile Resuscitation based on fixed dilated pupils, GCS3/15, absent pupillary and other brain stem reflexes in the absence of drug intoxications.
- •6.Pregnant females 7.Patients with Do Not Resuscitate (DNR) orders.
结局指标
主要结局
Primary Efficacy Endpoints:
时间窗: 1. at 24 hours | 2. Hospital discharge
1.Sustained Return of Spontaneous Circulation (ROSC): admission to ICU/wards with a palpable pulse and measurable BP.
时间窗: 1. at 24 hours | 2. Hospital discharge
2.Overall survival
时间窗: 1. at 24 hours | 2. Hospital discharge
3.Survival to 24 hrs: being alive 24hrs after the initial arrest.
时间窗: 1. at 24 hours | 2. Hospital discharge
4.Survival to hospital discharge: discharge to home or a chronic care facility
时间窗: 1. at 24 hours | 2. Hospital discharge
次要结局
- Secondary Efficacy Endpoints:(1.In patients with survival to discharge)