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

NCT ID: NCT06595043

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2025-12-31

Brief Summary

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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

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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

Conditions

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The Direction of Blocker Placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

the tip opening angle to the left

Intervention Type DEVICE

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

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.

Group Type PLACEBO_COMPARATOR

the tip opening angle to the right

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Wenfei Tan

Professor,Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wenfei Tan

Shenyang, , China

Site Status RECRUITING

the University Clinical Center of Serbia

Belgrade, , Serbia

Site Status NOT_YET_RECRUITING

Konkuk University School of Medicine

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Countries

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China Serbia South Korea

Central Contacts

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Wenfei Tan

Role: CONTACT

02483283100

Facility Contacts

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Xiuqi Yu

Role: primary

Marina Stojanović

Role: primary

Tae-Yop Kim

Role: primary

Other Identifiers

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20240910

Identifier Type: -

Identifier Source: org_study_id

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