Effect of Intraoperative Oxygen Tension on Patient Outcomes After Off-pump Coronary Artery Bypass Grafting (the CARROT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 2
- 主要终点
- hospital LOS
研究概览
简要总结
Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery including off-pump coronary artery bypass grafting (OPCAB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery has not been reached among practitioners yet. This study is a multicenter study (Seoul National University, Asan Medical Center, Severance Hospital) where the effect of different level of FiO2 on postoperative clinical outcomes is evaluated.
详细描述
A sub-study will also be conducted in part of patients of the present study. In 40 out of 500 (expected) patients, two different levels of FiO2 will be sequentially set with a 5-minute interval after the induction of general anesthesia. Mixed venous and regional cerebral oxygen saturation will then be recorded according to the change of FiO2.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for elective off-pump coronary artery bypass grafting
排除标准
- •emergency
- •robot-assisted surgery
- •minimally invasive cardiac surgery requiring thoracotomy/one-lung anesthesia
- •preoperative pulmonary morbidity requiring oxygen therapy
- •preoperative use of ECMO or IABP
- •preoperative tracheal intubation or mechanical ventilation
结局指标
主要结局
hospital LOS
时间窗: From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks
length of hospital stay after off-pump coronary artery bypass grafting
次要结局
未报告次要终点
研究者
Yunseok Jeon
Professor of Anesthesiology and Pain Medicine
Seoul National University Hospital