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NCT Number: NCT06595043

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wenfei Tan, Shenyang, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

the tip opening angle to the left

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

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.

Primary outcomes

  1. Satisfaction with the collapse of the right lung

    Time frame: 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 outcomes

  1. The first time success rate of blocker implantation

    Time frame: On the time of blocker implantation 30 seconds

    The first time success rate of blocker implantation

Study contacts

Contact information is provided by the study sponsor or research team.

Wenfei Tan

CONTACT

[email protected]

02483283100

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.