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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the tip opening angle to the left | Experimental | After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to left under the guidance of the fiber bronchoscope. |
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| the tip opening angle to the right | Placebo Comparator | After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to right under the guidance of the fiber bronchoscope. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the tip opening angle to the left | Device | After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to left under the guidance of the fiber bronchoscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with the collapse of the right lung | 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) | On the 3 minutes after one lung ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| The first time success rate of blocker implantation | The first time success rate of blocker implantation | On the time of blocker implantation 30 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenfei Tan | Contact | 02483283100 | wftan@cmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wenfei Tan | Recruiting | Shenyang | China |
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On the time of paper published
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| the tip opening angle to the right | Device | After fixing the position of the tracheal catheter, the opening of the tip of the blocker will be adjusted to right under the guidance of the fiber bronchoscope. |
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| the University Clinical Center of Serbia | Not yet recruiting | Belgrade | Serbia |
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| Konkuk University School of Medicine | Not yet recruiting | Seoul | South Korea |
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