Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation: a Multi-center, Prospective, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The Direction of Blocker Placement
- Sponsor
- China Medical University, China
- Enrollment
- 96
- Locations
- 3
- Primary Endpoint
- Satisfaction with the collapse of the right lung
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
Detailed Description
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
Investigators
Wenfei Tan
Professor,Chairman
China Medical University, China
Eligibility Criteria
Inclusion Criteria
- •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%.
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Satisfaction with the collapse of the right lung
Time Frame: 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)
Secondary Outcomes
- The first time success rate of blocker implantation(On the time of blocker implantation 30 seconds)