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

NCT ID: NCT06061055

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2024-11-26

Brief Summary

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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

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Conditions

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Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Anchor

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

Group Type EXPERIMENTAL

Intubation with VentiBronc Anchor endobronchial double-lumen tube

Intervention Type DEVICE

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

Shiley

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

Group Type ACTIVE_COMPARATOR

conventional double-lumen intubation

Intervention Type DEVICE

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

Interventions

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Intubation with VentiBronc Anchor endobronchial double-lumen tube

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

Intervention Type DEVICE

conventional double-lumen intubation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyuho Lee

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1-2023-0043

Identifier Type: -

Identifier Source: org_study_id