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Completed

NCT Number: NCT07117539

Impact of Different Lung Isolation Devices on Pharyngolaryngeal Injuries After Pulmonary Resection

The goal of this clinical trial is to assess the impact of laryngeal mask combined with visual bronchial blocker on pharyngolaryngeal injury after pulmonary resection in patients with pulmonary nodules. The main question it aims to answer is:

the incidence of postoperative pharyngolaryngeal injury within 24h : sore throat and hoarseness ? Researchers will compare the visual bronchial blocker group (VBB) with the double-lumen endotracheal tube group (DLT) to see if the visual bronchial blocker group can minimize laryngopharyngeal injury after pulmonary resection.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital, Shanghai, China

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About this study

Background: Video-assisted thoracoscopic surgery (VATS) necessitates effective lung isolation techniques. While double-lumen endotracheal tubes (DLT) remain the gold standard, they are associated with significant airway trauma and postoperative laryngopharyngeal morbidity. Laryngeal mask airway (LMA) combined with bronchial blockers represents a promising alternative; however, conventional bronchial blockers pose limitations including challenging positioning and potential airway injury. Novel visual bronchial blocker technology offers enhanced positioning accuracy and reduced airway manipulation, potentially minimizing laryngopharyngeal injury while maintaining effective lung isolation.

Objective: To compare the efficacy and safety of LMA combined with a visual bronchial blocker versus DLT for lung isolation in VATS, with a primary focus on reducing postoperative laryngopharyngeal injury.

Methods: This prospective, randomized, controlled, single-blind, multicenter clinical trial will enroll 270 patients scheduled for elective VATS anatomical lung resection. Participants will be randomly allocated (1:1 ratio) to either the visual bronchial blocker group (VBB group, n=135) or the DLT group (n=135) across three major thoracic surgery centers. The primary outcome is the incidence of laryngopharyngeal injury (sore throat and/or hoarseness) at 24 hours postoperatively. Secondary outcomes include laryngopharyngeal injury at 1 hour and 48 hours postoperatively, intraoperative device dislodgement, hypoxemia (SpO₂ < 90%), quality of lung collapse, airway instrumentation time, hemodynamic fluctuations, emergence quality, device-related complications, and hospital length of stay. Statistical analysis will be performed using SPSS 24.0, employing appropriate parametric and non-parametric tests.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Scheduled for elective VATS pulmonary resection under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body mass index (BMI) 18.5-30.0 kg/m²
  • Written informed consent

Exclusion criteria

  • Anticipated difficult airway (Mallampati class IV, previous difficult intubation, airway abnormalities)
  • Gastroesophageal reflux disease or gastric retention
  • Active pulmonary infection or bleeding
  • Severe pulmonary dysfunction (FEV1 <50% predicted)
  • Previous lung surgery or bilateral lung surgery
  • Cognitive impairment affecting outcome assessment
  • Chronic throat pain or voice abnormalities within 24 hours preoperatively
  • Abnormal right upper lobe bronchial anatomy on preoperative CT for right-sided procedures
  • Any condition deemed unsuitable for study participation by anesthesiologist or surgeon

Treatment and study plan

visual bronchial blocker (VBB)

Device

lung isolation with visual bronchial blocker

Double-lumen Endotracheal Tube (DLT)

Device

lung isolation with double-lumen endotracheal tube

Primary outcomes

  1. Incidence of pharyngolaryngeal injuries within postoperative 24 hours

    Time frame: within postoperative 24 hours

    sore throat and hoarseness

Secondary outcomes

  1. Incidence of pharyngolaryngeal injuries within postoperative an hour

    Time frame: within postoperative an hour

    sore throat and hoarseness

  2. Incidence of pharyngolaryngeal injuries within postoperative 48 hours

    Time frame: within postoperative 48 hours

    sore throat and hoarseness

  3. Intraoperative device displacement

    Time frame: during the operation

    lung re-expansion, airway pressure changes

  4. Intraoperative hypoxemia

    Time frame: during the operation

    SpO2 < 91%

  5. Lung collapse quality

    Time frame: at 5, 10, and 20 minute during single-lung ventilation

    The Lung Collapse Scale (LCS) is a standardized tool used in thoracic surgery to evaluate the degree of lung deflation during procedures requiring single-lung ventilation.(A score of 0: No lung collapse ; A score of 8: Satisfactory lung collapse.; A score of 10: Complete lung collapse )

  6. Intubation time

    Time frame: during anesthesia procedure

    from mouth opening to successful device placement

  7. Hemodynamic changes

    Time frame: during anesthesia procedure

    blood pressure variations before and after intubation

  8. Recovery quality: post-extubation cough

    Time frame: periprocedural (during anesthesia recovery)

    Post-extubation Cough Severity Scale (4-point Grading System) : Grade 0 (No cough); Grade 1( Mild cough: 1-2 episodes, duration <5 seconds ); Grade 2 (Moderate cough: 3-4 episodes, duration 5-15 seconds); Grade 3 (Severe cough ≥5 episodes, duration >15 seconds, with breath-holding and facial flushing)

  9. Device-related complications

    Time frame: during the operation

    intraoperative displacement, air leak, repositioning requirements

  10. Length of hospital stay

    Time frame: perioperative/periprocedural

    Surgery-to-Discharge Interval(SDI): measures the time from surgery end (e.g., leaving the operating room) to discharge.Assesses recovery efficiency and effectiveness of Enhanced Recovery After Surgery (ERAS) protocols.

Sponsors and collaborators

Lead sponsor

Tingting Li

Other

Collaborators

  • Charta Foundation

Registry information

Official study title

Impact of Laryngeal Mask Combined With Visual Bronchial Blocker on Pharyngolaryngeal Injuries After Pulmonary Resection

Acronym: PLIAP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Jan 15, 2026

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.

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