- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04948294
Comparison of the Intubation Condition Between Two Different Types of Video Laryngoscope Blades
October 26, 2023 updated by: Hyungseok Seo, Kyung Hee University Hospital at Gangdong
Comparison of the Intubation Condition Between Using Two Types of Blade in Patients Receiving Tracheal Intubation Using Videolaryngoscope: Channeled Blade vs. Non-channeled Blade
The present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade.
The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In tracheal intubation for general anesthesia, one of the two types of the blade during a video laryngoscopy can be used, one is a channeled blade that has a channel for tracheal tube launching, the other is a non-channeled blade.
In the present study, the outcomes by using two types of the videolaryngoscope blade such as the intubation condition, intubation time, first-pass rate, and the incidence of intubation-related complications were compared.
Study Type
Interventional
Enrollment (Actual)
118
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 Locations
-
-
-
Seoul, Korea, Republic of, 05278
- Kyung Hee University Gangdong Hospital
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients receiving tracheal intubation for general anesthesia
- Patients with physical status 1, 2, or 3 by American Society of Anesthesiologists Physical Status.
Exclusion Criteria:
- Body mass index <18.5 kg/m2 or >35 kg/m2
- Patients with a history of airway surgery
- Patients with increased risk of aspiration
- Patients who have any pathology (polyp, tumor, or inflammation) in the upper airway and larynx
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Channeled group
Group of patients using a channeled blade for videolaryngoscopy
|
In the present group, a tracheal tube was launched in the channel of the blade before tracheal intubation
|
|
Active Comparator: Non-channeled group
Group of patients using a non-channeled blade (standard type) for videolaryngoscopy
|
In the present group, a tracheal tube was not launched in the videolaryngoscope blade before tracheal intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation time
Time Frame: Immediately after tracheal intubation completed
|
the time for tracheal intubation
|
Immediately after tracheal intubation completed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-pass rate
Time Frame: Immediately after tracheal intubation completed
|
the success rate of tracheal intubation with one attempt
|
Immediately after tracheal intubation completed
|
|
Intubation-related complications
Time Frame: within 24 hours after surgery
|
the incidence of overall complications related with tracheal intubation
|
within 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hyungseok Seo, MD, PhD, Kyung Hee University Hospital at Gangdong
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 22, 2018
Primary Completion (Actual)
December 15, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
June 26, 2021
First Submitted That Met QC Criteria
June 30, 2021
First Posted (Actual)
July 1, 2021
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHNMC 2019-07-020-001
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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