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

Sponsor
Yunus Emre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05430425
Collaborator
(none)
240
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: respiratory safety

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Comparison of the Efficiency of Classical and I-GEL LMAs Selected by Different Methods in Providing a Safe Airway
Anticipated Study Start Date :
Jun 22, 2022
Anticipated Primary Completion Date :
Aug 7, 2022
Anticipated Study Completion Date :
Oct 22, 2022

Arms and Interventions

Arm Intervention/Treatment
body weight

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

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

thyromental distance

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

Other: respiratory safety
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

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

Outcome Measures

Primary Outcome Measures

  1. Selection of the appropriate supraglottic airway device for the patient [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yunus Emre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yunus Emre, SPECIALIST DOCTOR, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05430425
Other Study ID Numbers:
  • ytuncdemir-lma
First Posted:
Jun 24, 2022
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yunus Emre, SPECIALIST DOCTOR, Ankara Training and Research Hospital

Study Results

No Results Posted as of Jun 24, 2022