Clinical Application of Right Visual Double Lumen Tube in Thoracoscopic Surgery for Adult Patients

NCT07362797 | Not Yet Recruiting

• 1 other identifier: ZJU2025C144
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to understand whether a visual double-lumen intubation tube can improve the first-attempt success rate and reduce complications compared to a standard double-lumen tube. The trial primarily aims to answer the following questions: Does a double-lumen tube improve the first-attempt success rate? Does a visual double-lumen tube reduce the likelihood of obstruction of the right upper lobe bronchial opening? Does a visual double-lumen tube require fewer adjustments during surgery? Do patients with visual double-lumen tubes experience fewer perioperative complications compared to those with standard double-lumen tubes? Participants will: Use a visual double-lumen tube partially and a standard double-lumen tube partially. Record the perioperative status of all patients.

Conditions

Thoracoscopic Surgery; Double Lumen Tube Intubation

Keywords

double lumen tube; FOB; thoracoscopic surgery; Visual dual-lumen tube

Outcome Measures

Primary Outcomes (1)

• Primary purpose

  To study whether the right visual double lumen tube can improve the success rate of initial intubation compared with the right ordinary double lumen tube.

  After anesthesia induction, the laryngoscope is inserted and the timing begins until the endotracheal tube position is confirmed. The endotracheal tube is then fixed, and mechanical ventilation is initiated (approximately 10 minutes).

Secondary Outcomes (3)

• Secondary purposes

  After the endotracheal tube is secured, the patient is ventilated by a ventilator, and ventilation of the right single lung is initiated (lasting approximately 2-3 minutes).

• Intraoperative cannulation position adjustment

  The entire surgery (approximately 1-3 hours).

• postoperative complications

  From the end of surgery to the patient's discharge (2-3 days).

Study Arms (2)

visual double-lumen tube group

ACTIVE COMPARATOR

Lung-isolation thoracoscopic surgery using a right-side visual double-lumen tube.

Device: visible double-lumen tube

Non-visual dual-lumen tube (ordinary dual-lumen tube) group

ACTIVE COMPARATOR

Lung isolation thoracoscopic surgery was performed with fiberoptic bronchoscopy assistance using a standard double-lumen tube on the right side (non-visual double-lumen tube).

Device: lumen intubation tube

Interventions

lumen intubation tube DEVICE

The standard double-lumen tube on the right side was positioned with the aid of a fiberoptic bronchoscope.

Also known as: lumen intubation tube group

Non-visual dual-lumen tube (ordinary dual-lumen tube) group

visible double-lumen tube DEVICE

A visible double-lumen tube on the right side

Also known as: visible double-lumen tube group

visual double-lumen tube group

Eligibility Criteria

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

You may qualify if:

• Age: at least 18 years old, gender is not limited.
• American Anesthesiologists Association (ASA) Grade I-III;
• Elective Video-Assisted Thoracoscopic Lobectomy.
• Informed consent of the patient or family member.
• People who are willing to accept perioperative visits.

You may not qualify if:

• Patients with contraindications for right double-lumen tube insertion (such as right bronchial tumor).
• The patient has known tracheobronchial anatomical abnormalities
• Patients previously diagnosed or suspected of having airway difficulty.
• Patients who need rapid sequence induction.
• Patients requiring emergency surgery
• Patients who have undergone thoracic surgery, systemic infection or suspected tuberculosis in the past four weeks.

Sponsors & Collaborators

• Diansan Su: lead
• Ningbo No.2 Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine,

Hangzhou, Zhejiang, 310000, China

Location

Central Study Contacts

Heng Wen

CONTACT

+8615158080827; zyyywenheng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-12

Locations

CN (1)