Intraoperative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- arterial PO2/FiO2 Ratio
研究概览
简要总结
This study is a prospective observer blinded, central randomization controlled, multi-center clinical trial to assess the relationship between intraoperative FiO2 and postoperative pulmonary complications with lung injury.
详细描述
Hyperoxia is common in cardiac surgery and is easy to prevent by adjusting FiO2. Since there is no prospective study on different FiO2 and postoperative pulmonary complications (PPCs) during cardiac surgery. We hypothesized that hyperoxia during cardiac surgery could lead to higher incidence of lung injury and PPCs than normoxia. The objective of this trial is to compare postoperative PPCs and other outcomes between hyperoxia and normoxia strategy by PaO2/FiO2 in CABG patients.
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
- Single (Outcomes Assessor)
盲法说明
The research fellows and ICU physicians who record and assess the primary and secondary outcomes will be blinded to the group assignment. The principal investigator (PI) of every center and the physicians who conduct the anesthesia and monitoring intraoperatively in operating room are unblinded.
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
- •Age from 18 to 75
- •BMI from 20 to 39.9
- •ASA II/III
- •Undergoing isolated selective on-pump CABG through median sternotomy
- •Subsequent admission to an intensive care unit (ICU).
排除标准
- •with severe chronic obstructive pulmonary disease (COPD)
- •Pregnant woman.
- •With current acute coronary syndrome (<1 week)
- •Severe anemia (hemoglobin <10g/L)
- •Preoperative supplemental oxygen requirement to maintain arterial O2 of 92%,
- •Right to left shunt in heart
- •Carotid stenosis defined as >50% stenosis of either carotid artery,
- •Cardiac surgery that requires intraoperative circulatory arrest,
- •Current use of dialysis,
- •One-lung ventilation during surgery,
- •Recent smoking (within 1 month),
- •Non-respiratory reason to reintubate or delayed extubation such as bleeding or heart failure,
- •Perioperative allogenic transfusion with red blood cell, plasma or platelet
结局指标
主要结局
arterial PO2/FiO2 Ratio
时间窗: 48hr post operation
minimal postoperative arterial PO2/FiO2 Ratio
次要结局
- Pulmonary complications(up to one week while in the hospital)
- length of mechanical ventilation(up to one week while in the hospital)
- length of hospital stay(up to one week while in the hospital)
- length of postoperative ICU stay(up to one week while in the hospital)
研究者
Jiapeng Huang
Principal Investigator
University of Louisville