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

September 22, 2023 updated by: Yonsei University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anchor
Patient group who are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor)
Device: Intubation with VentiBronc Anchor endobronchial double-lumen tube
Patients in this group are intubated with triple-cuffed double-lumen endobronchial tube (VentiBronc Anchor).
Active Comparator: Shiley
Patient group who are intubated with conventional double-lumen endobronchial tube (Shiley)
Device: conventional double-lumen intubation
Patients in this group are intubated with conventional double-lumen endobronchial tube (Shiley).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of endobronchial intubation
Time Frame: 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.
Immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Kyuho Lee, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1-2023-0043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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