Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
研究概览
简要总结
The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.
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
- 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
- •Major patient ≥ 18 years
- •Patient operated cardiac surgery for myocardial revascularization (CABG) or surgical correction of valvular or combined surgery (CABG and valve disease) or ascending aortic surgery
- •Signed Consent
- •Affiliation to social security
排除标准
- •Permanent atrial fibrillation
- •Cordarone therapy,
- •Pregnant woman
- •Patient under guardianship or trusteeship or private public law
- •Internal pacemaker
- •Hypothermia,
- •Patient refusal,
- •Cardiac surgery without extracorporal circulation (ECC),
- •Participation in another study.
研究组 & 干预措施
normoxia
During cardiopulmonary bypass inspired fraction of oxygen is adapted to maintained a oxygen arterial pressure below 150 mmHg.
干预措施: medical oxygen (Drug)
hyperoxia
During cardiopulmonary bypass inspired fraction of oxygen is set to 100 %.
干预措施: medical oxygen (Drug)
结局指标
主要结局
Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
时间窗: 15 days after surgery
次要结局
未报告次要终点