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Clinical Trials/NCT05430425
NCT05430425
Unknown
Not Applicable

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

Yunus Emre0 sites240 target enrollmentJune 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Complication of Anesthesia
Sponsor
Yunus Emre
Enrollment
240
Primary Endpoint
Selection of the appropriate supraglottic airway device for the patient
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 22, 2022
End Date
October 22, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Yunus Emre
Responsible Party
Sponsor Investigator
Principal Investigator

Yunus Emre

SPECIALIST DOCTOR

Ankara Training and Research Hospital

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.

Outcomes

Primary Outcomes

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

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