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

NCT05430425 | Unknown

• 1 other identifier: ytuncdemir-lma
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Airway Complication of Anesthesia

Keywords

anesthesia; laryngeal mask; safe respiratory tract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

body weight

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

Other: respiratory safety

thyromental distance

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

Other: respiratory safety

resize with 3 fingers

grup p; igel=n:40 clasic lma n=40

Other: respiratory safety

Interventions

respiratory safety OTHER

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

body weight; resize with 3 fingers; thyromental distance

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \>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.

Sponsors & Collaborators

• Yunus Emre: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: SPECIALIST DOCTOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 24, 2022
• Study Start: June 22, 2022
• Primary Completion: August 7, 2022
• Study Completion: October 22, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06