Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery

NCT07849400 | Not Yet Recruiting

• 1 other identifier: ZJU20260827
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 3

Brief Summary

Right-sided double-lumen tubes are used for lung isolation during thoracoscopic surgery but can be difficult to position because of right bronchial anatomy. This multicenter randomized controlled trial will compare a continuous video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adult patients undergoing thoracoscopic surgery requiring right-sided lung isolation. The primary objective is to determine whether continuous video guidance increases the rate of successful initial right-sided double-lumen tube positioning. Secondary outcomes include positioning time, clinically relevant intraoperative tube displacement, rescue fiberoptic bronchoscopy, lung collapse quality, hypoxemia during one-lung ventilation, and airway-related complications.

Conditions

Right-sided Double-lumen Tube Positioning; Lung Isolation During Thoracoscopic Surgery; One-lung Ventilation; Lung Cancer; Pulmonary Nodules; Mediastinal Tumors; Thoracoscopic Surgery Requiring One-lung Ventilation

Outcome Measures

Primary Outcomes (1)

• Number of participants with successful initial right-sided double-lumen tube positioning assessed by fiberoptic bronchoscopy

  Successful initial positioning is defined as Grade 1 (optimal) or Grade 2 (acceptable) tube position at the first protocol-mandated fiberoptic bronchoscopic assessment before any bronchoscopic adjustment. Grade 3 (malposition) is considered unsuccessful. Successful positioning requires an acceptable bronchial cuff position, adequate alignment of the right upper-lobe ventilation slot with the right upper-lobe bronchial orifice, absence of clinically relevant right upper-lobe obstruction, and a patent bronchus intermedius without the need for further advancement, withdrawal, or rotation of the tube. Each participant will be classified as successful or unsuccessful.

  Intraoperatively, immediately after initial tube positioning and before initiation of one-lung ventilation.

Secondary Outcomes (5)

• Time to initial right-sided double-lumen tube positioning

  Periprocedural, during initial right-sided double-lumen tube positioning.

• Number of unplanned intraoperative right-sided double-lumen tube repositioning events per participant

  Intraoperatively, from confirmation of satisfactory initial tube position until completion of one-lung ventilation.

• Quality of surgical lung collapse assessed by a 3-point surgeon-rated scale

  Intraoperatively, approximately 20 minutes after initiation of one-lung ventilation.

• Number of hypoxemic episodes during one-lung ventilation per participant

  Intraoperatively, during one-lung ventilation.

• Airway-related complications

  From airway instrumentation until 24 hours after surgery.

Study Arms (2)

Continuous video-guided right-sided double-lumen tube

EXPERIMENTAL

Device: Continuous video-guided right-sided double-lumen tube

Conventional right-sided double-lumen tube

ACTIVE COMPARATOR

Device: Conventional right-sided double-lumen tube

Interventions

Continuous video-guided right-sided double-lumen tube DEVICE

Participants will receive a continuous video-guided right-sided double-lumen tube for lung isolation during thoracoscopic surgery. The device incorporates an integrated visualization system that provides continuous real-time airway visualization during tube positioning and intraoperative management.

Continuous video-guided right-sided double-lumen tube

Conventional right-sided double-lumen tube DEVICE

Participants will receive a conventional right-sided double-lumen tube for lung isolation during thoracoscopic surgery according to standard clinical practice.

Conventional right-sided double-lumen tube

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Patients scheduled for elective thoracoscopic surgery requiring lung isolation with a right-sided double-lumen tube.
• Patients who provide written informed consent.

You may not qualify if:

• Contraindications to placement of a right-sided double-lumen tube, including right main bronchial lesions that preclude its use.
• Known tracheobronchial anatomical abnormalities.
• Known or anticipated difficult airway.
• Requirement for rapid sequence induction.
• Emergency surgery.
• Thoracic surgery within 4 weeks before enrollment, recent respiratory infection, or known or suspected pulmonary tuberculosis.
• Severe respiratory instability.
• Concurrent participation in another interventional clinical trial that may affect the study outcomes.

Sponsors & Collaborators

• Diansan Su: lead

Study Sites (3)

The First Affiliated Hospital, Zhejiang University School of Medicine,

Hangzhou, Zhejiang, 310000, China

Location

Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）

Jiaxing, Zhejiang, 314000, China

Location

The Second Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Heng Wen

CONTACT

+86057187236169; wen_heng@yeah.net

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: Chief Investigator, Department of Anesthesiology

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

CN (3)