Does Venous Cannulation Method Affect Air Embolic Load to the Patient During Extracorporeal Circulation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference in volume (nano liter) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
研究概览
简要总结
The goal of this single center prospective controlled observational and interventional trial is to investigate and compare origin of air emboli when different venous cannulation methods is used in patients undergoing cardiac surgery with extracorporeal circulation.
40 consecutive elective patients will be included in two groups, depending on the procedure requiring bicaval or cavoatrial cannulation. After assorted into respective group, patients will be block randomized (five groups consisting of eight patients each) to either intervention group (low venous reservoir volume, 200-300 mL) or control group (venous reservoir volume > 300 mL).
Primary endpoint is to investigate if the amount of air emboli passing through the oxygenator to the arterial line differs between bicaval and cavoatrial venous cannulation during extracorporeal circulation. Secondary endpoints are the relative difference in amount air emboli between the groups, if there is any correlation between the amount of air in venous line and the amount of air passing through the oxygenator to the arterial line during extracorporeal circulation, and if difference is seen on the amount of air passing through the oxygenator depending on the level of volume in the venous reservoir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Patients > 18 years
- •Elective bicaval cannulation (mitral valve repair/replacement (MVR) or MVR + coronary artery bypass grafting (CABG))
- •Elective cavoatrial cannulation (aortic valve repair/replacement (AVR) or AVR + CABG
- •Planned normothermia (35-37˚C)
排除标准
- •Acute heart surgery
- •Adult Congenital Heart Disease (ACHD) surgery
- •Endocarditis
- •Reoperation (primary procedure > 2 years ago)
- •Perioperative iatrogenic adverse events (major bleeding, aortic dissection, other severe complications)
结局指标
主要结局
Difference in volume (nano liter) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
时间窗: 1 day (During extracorporeal circulation)
Bubble counter measurements
Difference in count (number) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
时间窗: 1 day (During extracorporeal circulation)
Bubble counter measurements
次要结局
- Difference in amount of air passing through the oxygenator depending on the volume in the venous reservoir (200-300 mL versus > 300 mL).(1 day (During extracorporeal circulation))
- Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.(1 day (During extracorporeal circulation))
- Correlation between the amount of air in venous line and the amount of air passing through the oxygenator to the arterial line during extracorporeal circulation.(1 day (During extracorporeal circulation))
研究者
Petronella Torild
Perfusionist aspirant
Sahlgrenska University Hospital