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Recruiting NCT06595043

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

No phase Interventional The Direction of Blocker Placement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: the tip opening angle to the left, the tip opening angle to the right.
Who it may be relevant to
Registry conditions: The Direction of Blocker Placement. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China, Serbia, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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

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

Interventions

  • Device 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.
  • 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.

Primary outcome measures

  • Satisfaction with the collapse of the right lung [Time frame: On the 3 minutes after one lung ventilation]
Secondary outcome measures (1)
  • The first time success rate of blocker implantation [Time frame: On the time of blocker implantation 30 seconds]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Wenfei Tan — Shenyang
Serbia · 1 center
  • the University Clinical Center of Serbia — Belgrade
South Korea · 1 center
  • Konkuk University School of Medicine — Seoul

Identifiers

NCT: NCT06595043 · 20240910

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗