NCT04311775

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1 month

First QC Date

March 10, 2020

Last Update Submit

August 20, 2021

Conditions

Keywords

laryngeal mask

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

video laryngoscopy

video laryngoscope is a camera laryngoscope system used to see the larynx with camera

Device: larengeal mask insertion with video laryngoscopy

laryngoscopy

laryngoscopy is a method used to see the larynx.

Other: laryngeal mask insertion

Interventions

it is a method of inserting a laryngeal mask into the airway with videolaryngoscopy

video laryngoscopy

laryngeal mask is a method of inserting atube into the upper airway

laryngoscopy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ASA1,2,3 group patients to insertion of laryngeal mask

You may qualify if:

  • Patients between 18-65 years old
  • ASA1,2,3 group patients
  • Patients undergoing general anesthesia Patients scheduled for elective surgery

You may not qualify if:

  • The patient's refusal to participate in the study
  • Contraindication for placement of the laryngeal mask

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tahsin Şimşek

Istanbul, Kartal, 34000, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 17, 2020

Study Start

January 20, 2021

Primary Completion

February 20, 2021

Study Completion

February 27, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations