Comparison of VentiBroncTM Anchor With Conventional Double-lumen Endobronchial Tube in Patients With High Risk of Malposition

NCT06061055 | Completed

• 1 other identifier: 1-2023-0043
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators intend to compare the group using triple-cuffed endobronchial tube (VentiBroncTM Anchor) with the group using the conventional double-lumen endotracheal tube (Shiley®) in patients at high risk of malposition of the double-lumen endotracheal tube. The aim of this study is to determine if the use of VentiBroncTM Anchor increases the success rate of optimal double-lumen intubation to left main bronchus.

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• Success rate of endobronchial intubation

  Success or failure of endobronchial intubation will be determined immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope.

  Immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope

Study Arms (2)

Anchor

EXPERIMENTAL

Patient group who are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor)

Device: Intubation with VentiBronc Anchor endobronchial double-lumen tube

Shiley

ACTIVE COMPARATOR

Patient group who are intubated with conventional double-lumen endobronchial tube (Shiley)

Device: conventional double-lumen intubation

Interventions

Intubation with VentiBronc Anchor endobronchial double-lumen tube DEVICE

Patients in this group are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor).

Anchor

conventional double-lumen intubation DEVICE

Patients in this group are intubated with conventional double-lumen endobronchial tube (Shiley).

Shiley

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring left double-lumen endotracheal tube intubation for thoracic surgery.
• ASA physical status classification 2-4. Female patients aged 20-85 with a height of 160cm or less and a body mass index (BMI) of 25.0 kg/m2 or higher.
• Patients requiring VentiBroncTM Anchor 33Fr or Shiley® 32Fr intubation due to a left mainstem bronchus diameter of 11mm or less on chest CT.

You may not qualify if:

• Intraluminal lesions in the left or right mainstem bronchi. History of airway surgery. Emergency surgery.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim N, Oh YJ, Kim HJ, Lee K. Novel Triple-Cuff versus Conventional Double-Cuff Double-Lumen Endobronchial Tube in Patients with Risk Factors for Tube Misdirection. Yonsei Med J. 2025 Dec;66(12):866-873. doi: 10.3349/ymj.2025.0060.

  PMID: 41287499 DERIVED

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Kyuho Lee

  Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: October 26, 2023
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)