HELIox CardiOPlegia Trial During Cardiac surgERy
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility of using Heliox to oxygenate the blood cardioplegia
研究概览
简要总结
The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of administering Heliox in cardioplegia during cardiac surgery and whether it has the potential to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.
详细描述
The HELICOPTER-1 Trial is a single centre, randomized trial evaluating the feasibility of administration of Heliox for prevention of myocardial ischemia in patients undergoing cardiac surgery. Half of the study population will be randomly assigned to the receive cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture, while the other half will be randomized to receive the current clinical standard of care (nitrogen and oxygen in cardioplegia).
Subjects will be followed up daily during their post-operative course in hospital for clinical outcomes. A 30-day phone follow-up will be conducted for vital status and MI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age 18 or older
- •Cardiac surgery with CPB where use of a coronary sinus catheter is indicated
排除标准
- •Patient refusal
- •Recent myocardial infarction (less than 7 days old)
- •Left ventricular ejection fraction less than 30%
- •Known pregnancy on date of surgery
结局指标
主要结局
Feasibility of using Heliox to oxygenate the blood cardioplegia
时间窗: 30 days from the intervention
To determine the feasibility of using Heliox to oxygenate the blood cardioplegia. Feasibility will be measured according to subject enrollment rates and to measurement of the blood gas content of the cardioplegia solutions.
次要结局
- New Myocardial Infarction(30 days from the intervention)