Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation: a Multi-center, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- Satisfaction with the collapse of the right lung
研究概览
简要总结
This trial is a practical, multicenter, prospective, parallel grouping, randomized controlled,two-arm study. This study will be conducted in three centers including the First Hospital of China Medical University, Seoul National University Hospital and the University Clinical Center of Serbia. The investigators aim to investigate the effect of different occlusion angles of disposable tracheal blocker on right one-lung ventilation
详细描述
This trial is a practical, multi-center, prospective, parallel grouping, randomized controlled,two-arm clinical study comparing the different occlusion angles of disposable tracheal blocker on right one-lung ventilation. It is planned to enroll 96 subjects requiring right-sided One-Lung ventilation, aged 18-65 years, at three centers. Patients will be randomly assigned to the tip opening angle to the right (Group R), or he tip opening angle to the left (Group L). The primary outcome is the satisfaction with intraoperative collapse of the right lung. The secondary outcome is the one-time success rate of occuder implantation
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranged from 18 to 65 years old;
- •American Society of Anesthesiologists (ASA) grade I-III;
- •No history of drug allergy or abnormal anesthesia;
- •Patients undergoing right thoracoscopic surgery;
- •The preoperative oxygen saturation was not less than 94%.
排除标准
- •Patients with a history of acute lung injury or ARDS within 3 months;
- •Cardiac function class IV (New York Heart Association classification);
- •Chronic renal failure (renal cell filtration rate <30ml min-11.73m-2), severe liver disease;
- •Patients with blurred consciousness and cognitive dysfunction;
- •Patients with severe coagulation dysfunction;
- •Without preoperative oxygen inhalation, blood oxygen <94%, severe pulmonary dysfunction;
- •Patients with endotracheal tube admitted to ICU after operation;
- •Body mass index (BMI) >30;
- •Patients who had had lung surgery；
- •Inability to complete the study;
结局指标
主要结局
Satisfaction with the collapse of the right lung
时间窗: On the 3 minutes after one lung ventilation
The pirimary outcome is the comparison the effects of different occluder opening directions on lung collapse by one surgeon using lung collapse score (1-4, 4 means the best)
次要结局
- The first time success rate of blocker implantation(On the time of blocker implantation 30 seconds)
研究者
Wenfei Tan
Professor,Chairman
China Medical University, China