Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of maximal oxygen consumption in 3 months
研究概览
简要总结
Robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. Studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion volume during operation, re-operation rate, post-operation stroke rate and length of hospitalization. However, most studies focused on the comparison of complications of different procedures, and the investigation of cardiopulmonary function recovery is still lacking. Thus our study is to compare the functional outcomes between patients that undergo different surgical procedures.
详细描述
The study is a prospective cohort study. The experimental group will include 40 patients, consisting 20 after robotic coronary artery bypass grafting and 20 after robotic valvuloplasty. The control group will include 20 patients for each conventional procedure.
Once decided the surgery type, the surgeon will consult the rehabilitation department and the director of this trial for inform consent. The recruitment and allocation will only be done after the patient has decided which type of surgery to receive. However, in case of change of surgery type, the patient will be excluded from the trial.
Cardiopulmonary exercise testing, 6-minute walking test and questionnaires about wound pain and cardiac functional status will be performed before surgery, two weeks after discharge and three months after discharge respectively. Primary outcomes include the change of maximal oxygen consumption (VO2), anaerobic threshold and the result of six minute walking test before and after surgery. Secondary outcomes include the change vital capacity (FVC), resting heart rate, oxygen pulse (O2 pulse), wound pain visual analog scale (VAS) and Duke Activity Status Index (DASI) before and after surgery.
The hypothesis of this study is that patients who undergo robot-assisted surgery will have better cardiopulmonary outcomes than those receive conventional surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who undergo surgery for coronary artery bypass graft or valvular replacement.
排除标准
- •patients who receive more than one type of surgery
- •severe complications after surgery (ex. respiratory failure, stroke) and stayed in hospital for more than 2 weeks.
- •cannot perform the cardiopulmonary exercise testing
- •other contraindications for cardiopulmonary exercise testing
结局指标
主要结局
Change of maximal oxygen consumption in 3 months
时间窗: pre-operation to 3 months post-operation
the change of maximal oxygen consumption from before surgery to 3 months after surgery
Change of anaerobic threshold post surgery
时间窗: pre-operation to 2 weeks post-operation
the change of the onset of lactate accumulation in blood from before surgery to 2 weeks after surgery
Change of anaerobic threshold in 3 months
时间窗: pre-operation to 3 months post-operation
the change of the onset of lactate accumulation in blood from before surgery to 3 months after surgery
Change of six minute walking test result post-surgery
时间窗: pre-operation to 2 weeks post-operation
the change of six minute walking test result from before surgery to 2 weeks after surgery
Change of maximal oxygen consumption post-surgery
时间窗: pre-operation to 2 weeks post-operation
the change of maximal oxygen consumption from surgery before to 2 weeks after surgery
Change of six minute walking test result in 3 months
时间窗: pre-operation to 3 months post-operation
the change of six minute walking test result from before surgery to 3 months after surgery
次要结局
- Change of respiratory flow ratio in 3 months(pre-operation to 3 months post-operation)
- Change of resting heart rate in 3 months(pre-operation to 3 months post-operation)
- Change of oxygen pulse post-surgery(pre-operation to 2 weeks post-operation)
- Change of oxygen pulse in 3 months(pre-operation to 3 months post-operation)
- Change of activity status in 3 months(pre-operation to 3 months post-operation)
- Change of vital capacity post-surgery(pre-operation to 2 weeks post-operation)
- pain post-surgery(2 weeks post-operation)
- Change of resting heart rate post-surgery(pre-operation to 2 weeks post-operation)
- Change of vital capacity in 3 months(pre-operation to 3 months post-operation)
- Change of respiratory flow post-surgery(pre-operation to 2 weeks post-operation)
- pain in 3 months(3 months post-operation)
- Change of activity status post-surgery(pre-operation to 2 weeks post-operation)