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

NCT ID: NCT05430425

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2022-10-22

Brief Summary

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.

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

Conditions

Airway Complication of Anesthesia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

body weight

(grup VA; igel=n:40 clasic lma n=40),

respiratory safety

Intervention Type: OTHER

Which of the 3 lma selection methods is effective in ensuring respiratory safety?

thyromental distance

grup T; igel=n:40 clasic lma n=40)

respiratory safety

Intervention Type: OTHER

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

respiratory safety

Intervention Type: OTHER

Which of the 3 lma selection methods is effective in ensuring respiratory safety?

Interventions

respiratory safety

Which of the 3 lma selection methods is effective in ensuring respiratory safety?

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yunus Emre

OTHER

Sponsor Role: lead

Responsible Party

Yunus Emre

SPECIALIST DOCTOR

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

ytuncdemir-lma

Identifier Type: -

Identifier Source: org_study_id