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

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: Airway Complication of Anesthesia
• Intervention / Treatment: Other: respiratory safety

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

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

How is the study designed?

Number of groups / cohorts

3

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	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

• Sponsor: Yunus Emre

Study record dates

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: anesthesia; laryngeal mask; safe respiratory tract
• 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