Comparison of the Efficiency of Classical and I-GEL LMAs Selected by Different Methods in Providing a Safe Airway

June 22, 2022 updated by: Yunus Emre
In recent years, the use of laryngeal masks has been increasing in operating room and non-operating room anesthesia applications. Patients with inappropriate LMA may develop high leakages, gastric distension and inadequate ventilation during ventilation. If the laryngeal masks used to provide a safe airway in the patient are not selected in the appropriate size, adequate ventilation may not be provided, which may lead to various complications such as increased morbidity and mortality. In order to prevent and predict the bad results that may occur, we foresee which method can be chosen more appropriately for the patients and will guide the clinicians.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The laryngeal mask (LMA) is a subragglottic airway device commonly used to provide lung ventilation during general anesthesia. In this study, we aimed to compare the efficacy of classical and I-GEL LMA selected with different techniques.

Successful placement of the Laryngeal Mask Airway (LMA) largely depends on the correct size selection.

The size of the laryngeal mask airway is usually determined by the weight of the patient. However, in some cases an alternative method can be used. The weight of the patient is sometimes unknown (eg, obese, malnourished, sedentary or unconscious patients) and can be unpredictable, especially in children. Therefore, it will be useful to have alternative ways (according to 1. body weight, 2. thyromental distance, 3. dimensioning with three fingers) in determining the appropriate size of the laryngeal mask size. These different methods should be simple to perform and easy to remember.

LMA is increasingly used in elective surgery, resuscitation, difficult airway and emergency situations. Successful use of the LMA largely depends on the correct size selection, method of insertion, and cuff sealing. Placing an improperly sized LMA can result in incorrect positioning and incorrect ventilation

Study Type

Observational

Enrollment (Anticipated)

240

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

Probability Sample

Study Population

Cases aged between 18-65 years, whose elective consents have been obtained, and who will be placed under ASA I-II and LMA under general anesthesia will be included.

Description

Inclusion Criteria:

  • Elective cases between the ages of 18-65,
  • ASA I-II,
  • who will be fitted with an LMA by the anesthesia clinic,
  • and whose consent has been obtained

Exclusion Criteria:

->65 years old,

  • excessive cachectic or body mass index (BMI) >30 kg/m2,
  • those with high risk of regurgitation or aspiration (large hiatal hernia, Zenker's diverticulum, scleroderma, pregnancy, history of gastroesophageal reflux disease, uncontrolled diabetes mellitus and obesity),
  • potentially difficult airway (history of airway difficulty, mouth opening <2 cm,
  • Mallampati class 4,
  • limited neck extension or cervical spine pathology),
  • airway pathology,
  • decreased presence of pulmonary or chest wall compliance,
  • preoperative sore throat,
  • planned operation Patients with a duration of >2 hours and who need a prone position during surgery will not be included in the study.

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
body weight
(grup VA; igel=n:40 clasic lma n=40),
Other: respiratory safety
Which of the 3 lma selection methods is effective in ensuring respiratory safety?
thyromental distance
grup T; igel=n:40 clasic lma n=40)
Other: respiratory safety
Which of the 3 lma selection methods is effective in ensuring respiratory safety?
resize with 3 fingers
grup p; igel=n:40 clasic lma n=40
Other: respiratory safety
Which of the 3 lma selection methods is effective in ensuring respiratory safety?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Selection of the appropriate supraglottic airway device for the patient
Time Frame: three month
selecting the most appropriate laryngeal mask to ensure a safe airway. laryngeal mask; It can be selected according to body weight, thyromental distance and three finger size of the hand.Among these mask selection methods, the mask with the best effectiveness and the least complication will be selected
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunus Emre

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 (Anticipated)

June 22, 2022

Primary Completion (Anticipated)

August 7, 2022

Study Completion (Anticipated)

October 22, 2022

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ytuncdemir-lma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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