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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04311775
Other study ID # 2019/514/150/21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2021
Est. completion date February 27, 2021

Study information

Verified date August 2021
Source Kocaeli Derince Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date February 27, 2021
Est. primary completion date February 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
larengeal mask insertion with video laryngoscopy
it is a method of inserting a laryngeal mask into the airway with videolaryngoscopy
Other:
laryngeal mask insertion
laryngeal mask is a method of inserting atube into the upper airway

Locations

Country Name City State
Turkey Tahsin Simsek Istanbul Kartal

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli Derince Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The role of Videeolaryngoscope in Placement of Laryngeal Mask video laryngoscopy use in Larengeal Mask insertion, prevent complications of Larengeal mask. the study will comlete in two month
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