- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07241208
Comparison of Double-lumen Tube Intubation Between Fiberoptic Bronchoscopy and Video Laryngoscope
Effect of Combined Use of Flexible Bronchoscope on First-attempt Sucess in Tracheal Double Lumen Tube Intubation Using Videolaryngosocpe: A Randomized Controlled Trial
The goal of this clinical trial is to compare the first-attempt success rate in double-lumen tube intubation. The main question it aims to answer:
Is there any difference in the first-attempt success rate of intubation between using flexible bronchoscopy and a video laryngoscope? Researchers will compare the group using a flexible bronchoscope and video laryngoscope with the group using a video laryngoscope only to see if there is a difference in first-attempt success rate.
Participants will be intubated in one of two interventions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For double-lumen tube insertion, a video laryngoscope can usually be used. However, because the camera is located at the tip, there can be a difference between the line of sight and the actual glottic view, which may make double-lumen tube steering difficult.
Flexible bronchoscopy can guide the double-tube along the natural curvature of the airway with less trauma. In the present research, we hypothesized that the first-pass success rate may differ between a group using video laryngoscopy only and a group using video laryngoscopy and flexible bronchoscopy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyungseok Suh
- Phone Number: +82-10-2930-6885
- Email: seohyungseok@gmail.com
Study Locations
-
-
-
Seoul, South Korea, 06090
- Recruiting
- Kyung Hee University Hospital at Gangdong
-
Contact:
- Hyunseok Suh
- Phone Number: +82-10-2930-6885
- Email: seohyungseoK@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled operation
- Patients required to double lumen tube insertion for thoracic surgery
- ASA PS 1, 2, 3
Exclusion Criteria:
- BMI <18.5 or 35.0
- history of airway surgery
- suspicious of high aspiration risk
- Pathology in oropharynx or larynx such as tumor, poly, or inflammation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: VL
DLT intubation using video laryngoscope only
|
|
|
Active Comparator: VL+FOB
DLT intubation using video laryngoscope and fiberoptic bronchoscope
|
Use Fibertopic bronchoscopy for DLT intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
first attempt success rate
Time Frame: from enrollment to the end of tracheal intubation
|
The proportion of successful intubation at the first attempt
|
from enrollment to the end of tracheal intubation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KHNMC_IRB_202508009001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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