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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06061055
Collaborator
(none)
154
Enrollment
1
Location
2
Arms
11.6
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intubation with VentiBronc Anchor endobronchial double-lumen tube
  • Device: conventional double-lumen intubation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
154 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Comparison of VentiBroncTM Anchor With Conventional Double-lumen Endobronchial Tube in Patients With High Risk of Malposition
Actual Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Success rate of endobronchial intubation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT06061055
Other Study ID Numbers:
  • 1-2023-0043
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 29, 2023