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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2025-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pulmonary Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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visual bronchial blocker group（VBB）

Laryngeal Mask Airway(LMA) size selection based on patient weight (≥70kg: size 5, 50-70kg: size 4, \<50kg: size 3)；Standard LMA insertion technique in supine position；Visual bronchial blocker inserted through LMA central channel；Blocker advancement under direct vision to identify carina

Group Type EXPERIMENTAL

visual bronchial blocker (VBB)

Intervention Type DEVICE

lung isolation with visual bronchial blocker

double-lumen endotracheal tube group（DLT）

Size selection based on patient gender and height: Male: \>180cm (37F), 160-180cm (35F), \<160cm (32-35F)；Female: \>160cm (35F), \<155cm (32F), 155-160cm (individualized)；Standard laryngoscopy and DLT insertion；Fiberoptic bronchoscopy confirmation of positioning；Tracheal cuff pressure 25 cmH2O, bronchial cuff pressure 30 cmH2O

Group Type ACTIVE_COMPARATOR

double-lumen endotracheal tube (DLT)

Intervention Type DEVICE

lung isolation with double-lumen endotracheal tube

Interventions

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visual bronchial blocker (VBB)

lung isolation with visual bronchial blocker

Intervention Type DEVICE

double-lumen endotracheal tube (DLT)

lung isolation with double-lumen endotracheal tube

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No