跳至主要内容
临床试验/NCT05430425
NCT05430425Unknown不适用

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

Yunus Emre0 个研究点目标入组 240 人开始时间: 2022年6月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
240
主要终点
Selection of the appropriate supraglottic airway device for the patient

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • >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.

结局指标

主要结局

Selection of the appropriate supraglottic airway device for the patient

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Yunus Emre
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yunus Emre

SPECIALIST DOCTOR

Ankara Training and Research Hospital

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