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NCT06061055 Clinical Trial

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

Endotracheal Intubation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06061055
Other study ID # 1-2023-0043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 14, 2023
Est. completion date August 2024

Study information
Verified date September 2023
Source Yonsei University
Contact Kyuho Lee
Phone 82-02-2224-1636
Email theoneimlee@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 154
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Intubation with VentiBronc Anchor endobronchial double-lumen tube
Patients in this group are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor).
• conventional double-lumen intubation
Patients in this group are intubated with conventional double-lumen endobronchial tube (Shiley).

Locations
Country Name City State
Korea, Republic of Severance hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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