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

Not Applicable

Recruiting

• Conditions: The Direction of Blocker Placement
• Interventions: Device: the tip opening angle to the left; Device: the tip opening angle to the right

• Registration Number: NCT06595043
• Lead Sponsor: China Medical University, China

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

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-16
• Study Start: 2024-10-09
• Primary Completion: 2025-10-09
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the tip opening angle to the left	the 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.
the tip opening angle to the right	the 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The first time success rate of blocker implantation	On the time of blocker implantation 30 seconds	The first time success rate of blocker implantation

Trial Locations

Locations (3)

Wenfei Tan; 🇨🇳 Shenyang, China

Konkuk University School of Medicine; 🇰🇷 Seoul, Korea, Republic of

the University Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia