- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311775
Laryngeal Mask, Video Laryngoscopy
August 20, 2021 updated by: Tahsin Şimşek, Kocaeli Derince Education and Research Hospital
The Role of Video Laryngoscope in Laryngeal Mask Placement
LMA insertion provide an intact airway for many surgeries during general anesthesia .
LMA insertion technique was defined when it was first produced by Archie Brain .
Accordingly, it is recommended to advance the device to the level where resistance is felt blindly.
However, placing LMA may not always be smooth and uncomplicated.
Thus, gas leaks may occur and intragastric pressure increase may occur due to gastric insufflation.
To overcome these difficulties, the placement of the LMA under direct vision using a laryngoscope has been described in several studies .
Previous studies have shown that the reliability of the laryngeal mask can be demonstrated by the oropharyngeal cuff leak test .
In addition, the classification of the image of the laryngeal structures mediated by fiberoptic imaging and vocal cords from the LMA gives us information about the availability of effective positive pressure ventilation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
LMA insertion provide an intact airway for many surgeries during general anesthesia .
LMA insertion technique was defined when it was first produced by Archie Brain .
Accordingly, it is recommended to advance the device to the level where resistance is felt blindly.
However, placing LMA may not always be smooth and uncomplicated.
Thus, gas leaks may occur and intragastric pressure increase may occur due to gastric insufflation.
To overcome these difficulties, the placement of the LMA under direct vision using a laryngoscope has been described in several studies .
Previous studies have shown that the reliability of the laryngeal mask can be demonstrated by the oropharyngeal cuff leak test .
In addition, the classification of the image of the laryngeal structures mediated by fiberoptic imaging and vocal cords from the LMA gives us information about the availability of effective positive pressure ventilation.In cases where difficulties are found in laryngeal mask placement, using direct laryngoscope or videosingoscope, placement is frequently applied in anesthesia practice.
Kim GW et al investigated LMA placement with direct laryngoscope.
However, there is no study investigating the effectiveness of videongoscopes.
Videoingoscopes have wide viewing angles through their cameras located at the blade tips.
For this reason, we think that it will be advantageous in placing a laryngeal mask.
Study Type
Observational
Enrollment (Actual)
100
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
-
-
Kartal
-
İstanbul, Kartal, Turkey, 34000
- Tahsin Şimşek
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ASA1,2,3 group patients to insertion of laryngeal mask
Description
Inclusion Criteria:
- Patients between 18-65 years old
- ASA1,2,3 group patients
- Patients undergoing general anesthesia Patients scheduled for elective surgery
Exclusion Criteria:
- The patient's refusal to participate in the study
- Contraindication for placement of the laryngeal mask
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
video laryngoscopy
video laryngoscope is a camera laryngoscope system used to see the larynx with camera
|
it is a method of inserting a laryngeal mask into the airway with videolaryngoscopy
|
|
laryngoscopy
laryngoscopy is a method used to see the larynx.
|
laryngeal mask is a method of inserting atube into the upper airway
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The role of Videeolaryngoscope in Placement of Laryngeal Mask
Time Frame: the study will comlete in two month
|
video laryngoscopy use in Larengeal Mask insertion, prevent complications of Larengeal mask.
|
the study will comlete in two month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 20, 2021
Primary Completion (Actual)
February 20, 2021
Study Completion (Actual)
February 27, 2021
Study Registration Dates
First Submitted
March 10, 2020
First Submitted That Met QC Criteria
March 15, 2020
First Posted (Actual)
March 17, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2021
Last Update Submitted That Met QC Criteria
August 20, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019/514/150/21
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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