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

Not Applicable

Completed

• Conditions: Endotracheal Intubation
• Interventions: Device: Intubation with VentiBronc Anchor endobronchial double-lumen tube; Device: conventional double-lumen intubation

• Registration Number: NCT06061055
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-29
• Study Start: 2023-10-26
• Primary Completion: 2024-11-26
• Study Completion: 2024-11-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anchor	Intubation with VentiBronc Anchor endobronchial double-lumen tube	Patient group who are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor)
Shiley	conventional double-lumen intubation	Patient group who are intubated with conventional double-lumen endobronchial tube (Shiley)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of