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

Yonsei University

Status: Completed

Conditions: Endotracheal Intubation

Treatments: Device: conventional double-lumen intubation; Device: Intubation with VentiBronc Anchor endobronchial double-lumen tube

Study type: Interventional

Funder types: Other

Identifiers

NCT06061055

1-2023-0043

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Anchor

Experimental group

Description:

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

Treatment:

Device: Intubation with VentiBronc Anchor endobronchial double-lumen tube

Shiley

Active Comparator group

Description:

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

Treatment:

Device: conventional double-lumen intubation