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Pulmonary NeoplasmPLIAPNCT07117539

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

A study testing visual bronchial blocker (VBB) and double-lumen endotracheal tube (DLT) in people with Pulmonary Neoplasm, run by Tingting Li at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Neoplasm
What is being tested?
visual bronchial blocker (VBB) and double-lumen endotracheal tube (DLT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
3 sitesChina
Study dates
18 Aug 2025to 30 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • The Second Military Medical University Changhai Hospital

    Shanghai, 200433

Other trials in China

About this study

Official title: Impact of Laryngeal Mask Combined With Visual Bronchial Blocker 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.

Read the detailed description

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.

Being tested
visual bronchial blocker (VBB), double-lumen endotracheal tube (DLT)
Keywords
pulmonary resection, one-lung ventilation, pharyngolaryngeal injuries, lung isolation devices
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • visual bronchial blocker (VBB)Device

    lung isolation with visual bronchial blocker

  • double-lumen endotracheal tube (DLT)Device

    lung isolation with double-lumen endotracheal tube

Study groups in NCT07117539
Study groupRoleWhat they receive
visual bronchial blocker group（VBB）ExperimentalLaryngeal 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
Receives: Device: visual bronchial blocker (VBB)
double-lumen endotracheal tube group（DLT）Active comparatorSize 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
Receives: Device: double-lumen endotracheal tube (DLT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of pharyngolaryngeal injuries within postoperative 24 hours

    sore throat and hoarseness

    Measured: within postoperative 24 hours

Secondary outcomes (10)

  1. Incidence of pharyngolaryngeal injuries within postoperative an hour

    sore throat and hoarseness

    Measured: within postoperative an hour

  2. Incidence of pharyngolaryngeal injuries within postoperative 48 hours

    sore throat and hoarseness

    Measured: within postoperative 48 hours

  3. Intraoperative device displacement

    lung re-expansion, airway pressure changes

    Measured: during the operation

  4. Intraoperative hypoxemia

    SpO2 < 91%

    Measured: during the operation

  5. Lung collapse quality

    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 )

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

  6. Intubation time

    from mouth opening to successful device placement

    Measured: during anesthesia procedure

  7. Hemodynamic changes

    blood pressure variations before and after intubation

    Measured: during anesthesia procedure

  8. Recovery quality: post-extubation cough

    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)

    Measured: periprocedural (during anesthesia recovery)

  9. Device-related complications

    intraoperative displacement, air leak, repositioning requirements

    Measured: during the operation

  10. Length of hospital stay

    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.

    Measured: perioperative/periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start18 Aug 2025
  3. Primary completion31 Oct 2025
  4. Study completion30 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117539
Sponsor's protocol ID
JRH000032
Acronym
PLIAP
Status last verified
Jan 2026
First submitted
16 Jul 2025
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41469076

Questions about this trial

What is this clinical trial studying?

A study testing visual bronchial blocker (VBB) and double-lumen endotracheal tube (DLT) in people with Pulmonary Neoplasm, run by Tingting Li at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of pharyngolaryngeal injuries within postoperative 24 hours (time frame: within postoperative 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07117539, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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