One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pleural effusions after coronary artery bypass graft surgery
研究概览
简要总结
Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is usually taking to restore coronary revascularization, and its dissection can lead to accidental or voluntary pleural effusions. Respiratory complications are frequent, due to the drainage required. In this study, the investigators propose one-lung ventilation to facilitate artery grafting and surgical procedure. The investigators will include all adult patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in a prospective, controlled, randomized and monocentric study. The main objective is to demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined by presence of drainage and/or pneumothorax on X-ray chest in the ICU.
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
- 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
- •elective CABG surgery with internal thoracic artery, with patient consent.
- •Patient who have french social security
排除标准
- •Cardiac or thoracic past-history
- •polyurethane allergy
- •guardianship patient
- •endotracheal intern diameter too small to allow the EZ-Blocker introduction or the fiberscope
- •use of LASER immediately near the EZ-Blocker
研究组 & 干预措施
Standard group
bi lung ventilation usual practice
EZ-Blocker group
one lung ventilation 'EZ-Blocker'
干预措施: EZ-Blocker (Device)
结局指标
主要结局
Pleural effusions after coronary artery bypass graft surgery
时间窗: Day 0
quantifying the number of thoracic drains (0, 1 or 2), as accidental or voluntary pleural effusion
absence of pneumothorax
时间窗: Day 0
verify the absence of pneumothorax to X-ray chest ( not drained pleural effusion).
次要结局
未报告次要终点