Clinical trial NCT06595043: Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation
Official title: Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation: a Multi-center, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: The Direction of Blocker Placement
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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;

Primary outcomes:
measure: Satisfaction with the collapse of the right lung
timeFrame: On the 3 minutes after one lung ventilation
Secondary outcomes:
measure: The first time success rate of blocker implantation
timeFrame: On the time of blocker implantation 30 seconds
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Wenfei Tan
city: Seoul
country: Korea, Republic of
facility: Konkuk University School of Medicine
city: Belgrade
country: Serbia
facility: the University Clinical Center of Serbia
Study officials:
References: