Investigating the impact of tracheal blocker angles on lung ventilation during surgery

Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation: a Multi-center, Prospective, Randomized Controlled Trial

This study is testing how different angles of a tracheal blocker can improve lung ventilation for patients having right thoracoscopic surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: China Medical University, China (Academic / other)
• Locations: 3 sites (Shenyang and 2 other locations)
• Trial ID: NCT06595043 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized controlled study that aims to evaluate how different occlusion angles of a disposable tracheal blocker affect right one-lung ventilation in patients undergoing right thoracoscopic surgery. A total of 96 subjects aged 18-65 will be enrolled and randomly assigned to either a right or left tip opening angle of the blocker. The primary outcome will measure intraoperative satisfaction with lung collapse, while the secondary outcome will assess the success rate of the blocker implantation. The study will take place across three medical centers in China, South Korea, and Serbia.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 requiring right-sided one-lung ventilation for thoracoscopic surgery.

Not a fit: Patients with severe pulmonary dysfunction, recent acute lung injury, or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the effectiveness of one-lung ventilation techniques, leading to improved surgical outcomes for patients undergoing thoracoscopic procedures.

How similar studies have performed: While similar studies have explored lung ventilation techniques, this specific approach to occlusion angles is relatively novel and has not been extensively tested.

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;

Where this trial is running

Shenyang and 2 other locations

• Wenfei Tan — Shenyang, China (Recruiting)
• the University Clinical Center of Serbia — Belgrade, Serbia (Not_yet_recruiting)
• Konkuk University School of Medicine — Seoul, South Korea (Not_yet_recruiting)

Study contacts

• Study coordinator: Wenfei Tan

Conditions The Direction of Blocker Placement