The Direction of Blocker Placement
Conditions
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
Interventions
DEVICEthe tip opening angle to the left
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.
DEVICEthe tip opening angle to the right
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.
Sponsors
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the collapse of the right lung | 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
| Measure | Time frame | Description |
|---|---|---|
| The first time success rate of blocker implantation | On the time of blocker implantation 30 seconds | The first time success rate of blocker implantation |
Countries
China, Serbia, South Korea
Contacts
Primary ContactWenfei Tan
Outcome results
None listed