Clinical trial NCT05430425: Comparison of the Efficiency of Classical and I-GEL LMAs Selected by Different Methods in Providing a Safe Airway
Official title: Comparison of the Efficiency of Classical and I-GEL LMAs Selected by Different Methods in Providing a Safe Airway
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Airway Complication of Anesthesia
Keywords: anesthesia
laryngeal mask
safe respiratory tract
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Selection of the appropriate supraglottic airway device for the patient
timeFrame: three month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: