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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06061055
Enrollment
154
Registered
2023-09-29
Start date
2023-10-26
Completion date
2024-11-26
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation

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.

Interventions

DEVICEIntubation with VentiBronc Anchor endobronchial double-lumen tube

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

DEVICEconventional double-lumen intubation

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026