NCT07467005

Brief Summary

During thoracic surgery, double-lumen endotracheal intubation with one-lung ventilation is routinely performed to optimize surgical exposure, facilitate operative manipulation, and prevent iatrogenic lung injury. In patients undergoing repeat pulmonary surgery, prior lung resection may lead to pleural adhesions and tracheobronchial distortion, which substantially increase the difficulty of bronchial intubation. Even with experienced operators, the malposition rate of conventional double-lumen tubes remains high. The video double-lumen tube enables continuous visualization of the trachea and carina during insertion, positioning, and one-lung ventilation, allowing real-time airway monitoring. However, no clinical studies have specifically investigated airway management in patients undergoing redo pulmonary surgery. This study aimed to evaluate the efficacy and safety of the video double-lumen tube during anesthesia in patients undergoing secondary pulmonary resection.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Lung CancerPulmonary Nodule

Keywords

First-attempt Intubation Success RateOne-lung Ventilationvideo double-lumen tubesecondary pulmonary resection

Outcome Measures

Primary Outcomes (1)

  • Success rate of first-attempt bronchial intubation

    During the first intubation attempt

Secondary Outcomes (6)

  • Intubation time

    Measured from insertion of the video laryngoscope into the mouth until confirmation of correct tube position

  • Requirement for and number of fiberoptic bronchoscopy uses

    During the entire intraoperative period

  • Frequency of intraoperative tube repositioning

    During the entire intraoperative period

  • Surgeon's rating of lung collapse quality

    During the entire intraoperative period

  • Incidence of difficult intubation

    At the time of intubation

  • +1 more secondary outcomes

Other Outcomes (1)

  • Incidence of intraoperative hypoxemia

    During the entire intraoperative period

Study Arms (2)

Video Double-Lumen Tube Group

EXPERIMENTAL
Device: Video Double-Lumen Tube Group

Conventional Double-Lumen Tube

ACTIVE COMPARATOR
Device: Conventional Double-Lumen Tube Group

Interventions

Video Double-Lumen Tube GroupDEVICE

Use the video double-lumen tube to perform left bronchial intubation under real-time visualization and continuously monitor its position.

Video Double-Lumen Tube Group
Conventional Double-Lumen Tube GroupDEVICE

Insert a conventional left-sided double-lumen tube using standard intubation techniques.

Conventional Double-Lumen Tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • History of previous pulmonary resection.
  • Scheduled for elective pulmonary surgery.
  • Planned to receive a left-sided double-lumen tube.
  • ASA physical status I-III.
  • Patients have signed the informed consent form.

You may not qualify if:

  • Preoperatively predicted difficult airway (Mallampati ≥ III, Cormack-Lehane ≥ III).
  • Acute respiratory distress syndrome (ARDS) or respiratory failure within the past 3 months.
  • Uncontrolled asthma.
  • Confirmed pregnancy or current breastfeeding.
  • Multiple traumatic injuries.
  • Current participation in another clinical trial.
  • Other conditions deemed unsuitable by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Zhejiang Cancer hospital

Hangzhou, Zhejiang, 310000, China

Location

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Diansan Su

CONTACT

+86 18616514088diansansu@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician,Researcher

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 5, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

CN(3)