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

China Medical University, China96 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

The Direction of Blocker Placement

Interventions

the tip opening angle to the leftDEVICE

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.

the tip opening angle to the rightDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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;

Locations (3)

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

Outcomes

Primary Outcomes

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)

Time frame: On the 3 minutes after one lung ventilation

Secondary Outcomes

The first time success rate of blocker implantation

Time frame: On the time of blocker implantation 30 seconds

Central Contacts

Wenfei Tan

CONTACT

02483283100 wftan@cmu.edu.cn

Data from ClinicalTrials.gov

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