Effects of Different Occlusion Angles of Disposable Tracheal Blocker on Right One-lung Ventilation

China Medical University, China

Status: Enrolling

Conditions: The Direction of Blocker Placement

Treatments: Device: the tip opening angle to the right; Device: the tip opening angle to the left

Study type: Interventional

Funder types: Other

Identifiers

NCT06595043

20240910

Details and patient eligibility

About

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

Full 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

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

the tip opening angle to the left

Experimental group

Description:

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.

Treatment:

Device: the tip opening angle to the left

the tip opening angle to the right

Placebo Comparator group

Description:

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.

Treatment:

Device: the tip opening angle to the right