Effect of Small Double-lumen Tube on the Intubation Time of Thoracoscopic Pulmonectomy in Asian Women

NCT07097584 | Completed DMC

• 1 other identifier: IRB-2025-841
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this experiment is to verify whether selecting a double-lumen tube one size smaller based on the traditional personalized method can shorten the intubation time without increasing ventilation complications when performing tracheal intubation for thoracic surgery in Asian women.Patients receive double-lumen tubes of a size selected based on the traditional personalized method or one size smaller than that chosen by the traditional method during tracheal intubation. The primary outcome is the time duration required to complete Double-lumen tube intubation and positioning.

Conditions

Women; Asian; Thoracic Surgery With One-lung Ventilation

Outcome Measures

Primary Outcomes (1)

• Intubation allocation time

  The time duration required to complete Double-lumen tube intubation and positioning

  During induction of general anesthesia

Secondary Outcomes (34)

• Time of laryngoscope insertion

  During induction of general anesthesia

• Time of double-lumen tube insertion

  During induction of general anesthesia

• Time of successfully positioning of fiberoptic bronchoscope in supine position

  During induction of general anesthesia

• First-pass success rate of intubation

  During induction of general anesthesia

• Number of intubation attempts

  During induction of general anesthesia

Study Arms (2)

The Down-size Left Double-lumen Endobronchial Tube Group

EXPERIMENTAL

Device: Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method

The Regular Left Double-lumen Endobronchial Tube Group

ACTIVE COMPARATOR

Device: Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods

Interventions

Selecting the size of a Left Double-lumen endobronchialtube one size smaller than the traditional method DEVICE

During tracheal intubation，choose a Left Double-lumen Endobronchial Tubethat is one size smaller than the traditional method.In this study, all patients planned to be enrolled are female. In experimental group the relationship between height and size is roughly as follows: For patients with a height between 152 - 165 cm, a 32Fr (French) tube is often selected. For patients with a height between 165 - 177 cm, a 35Fr tube is often selected. For patients with a height of more than 177 cm, a 37Fr tube is often selected.

The Down-size Left Double-lumen Endobronchial Tube Group

Selecting the size of a Left Double-lumen endobronchialtube according to traditional methods DEVICE

During tracheal intubation，choose the regular Left Double-lumen endobronchial tube according to the traditional method. The selection of double-lumen tube sizes using traditional methods relies on two factors: height and gender. In this study, all patients planned to be enrolled are female, so the traditional corresponding relationship is roughly as follows: For patients with a height of less than 152 cm, a 32Fr (French) tube is often selected. For patients with a height between 152 - 165 cm, a 35Fr tube is often selected. For patients with a height between 165 - 177 cm, a 37Fr tube is often selected. For patients with a height of more than 177 cm, a 39Fr tube is often selected.

The Regular Left Double-lumen Endobronchial Tube Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for thoracoscopic pulmonary resection using a left double-lumen tube under general anesthesia.
• Patients aged 18-80 years
• Chest CT scan in our hospital within one month before surgery
• American Society of Anesthesiologists (ASA) physical status I to III

You may not qualify if:

• Anticipated difficult airway
• Patients with tracheal/left main bronchus anomalies
• Height \<152 cm
• Refused to participate in the study

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologists do not implement the blinding method for the patient grouping, while the physicians conducting the postoperative follow-up implement the blinding method for the grouping.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 31, 2025
• Study Start: July 15, 2025
• Primary Completion: December 22, 2025
• Study Completion: January 23, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: starting about 6 months after publication

Locations

CN (1)