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

NCT07117539 | Completed DMC

• 1 other identifier: JRH000032
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pulmonary Neoplasm

Keywords

pulmonary resection; one-lung ventilation; pharyngolaryngeal injuries; lung isolation devices

Outcome Measures

Primary Outcomes (1)

• Incidence of pharyngolaryngeal injuries within postoperative 24 hours

  sore throat and hoarseness

  within postoperative 24 hours

Secondary Outcomes (10)

• Incidence of pharyngolaryngeal injuries within postoperative an hour

  within postoperative an hour

• Incidence of pharyngolaryngeal injuries within postoperative 48 hours

  within postoperative 48 hours

• Intraoperative device displacement

  during the operation

• Intraoperative hypoxemia

  during the operation

• Lung collapse quality

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

Study Arms (2)

visual bronchial blocker group（VBB）

EXPERIMENTAL

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

Device: visual bronchial blocker (VBB)

double-lumen endotracheal tube group（DLT）

ACTIVE COMPARATOR

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

Device: double-lumen endotracheal tube (DLT)

Interventions

visual bronchial blocker (VBB) DEVICE

lung isolation with visual bronchial blocker

visual bronchial blocker group（VBB）

double-lumen endotracheal tube (DLT) DEVICE

lung isolation with double-lumen endotracheal tube

double-lumen endotracheal tube group（DLT）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tingting Li: lead
• Charta Foundation: collaborator

Study Sites (3)

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

The Second Military Medical University Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (1)

• Zhang Y, Li T, Wei J, Bao R, Lv X, Wang JF, Wu J. Laryngeal mask airway combined with visual bronchial blocker versus double-lumen tube for lung isolation in video-assisted thoracoscopic surgery: a protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Dec 30;15(12):e110539. doi: 10.1136/bmjopen-2025-110539.

  PMID: 41469076 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jingxiang Wu

  Shanghai Chest Hospital

  STUDY DIRECTOR

• Tingting Li

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 12, 2025
• Study Start: August 18, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)