Comparison of the LMA Protector and the I-gel

SMG-SNU Boramae Medical Center110 enrolled

Overview

Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

110

Conditions

Mechanical Ventilation

Interventions

I-gelDEVICE

After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.

Laryngeal mask airway protectorDEVICE

After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Requirement for mechanical ventilation under general anesthesia Exclusion Criteria: * Surgical position other than supine position * Tumors or anatomical abnormalities in the upper airway * Known or predicted difficult airway * Body mass index \> 30 kg/m2 * Required postoperative mechanical ventilation * Head and neck surgery * Aspiration tendency

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Oropharyngeal airway leak pressure

Oropharyngeal airway leak pressure is measured by closing the expiratory valve of the circle system at a fresh gas flow of 3 L/min and observing the airway pressure at equilibrium.

Time frame: At 5 min after the insertion of i-gel or LMA protector

Secondary Outcomes

Number of insertion attempt for the successful placement

The numbers of insertion attempt for successful placement are counted.

Time frame: During the insertion of i-gel or LMA protector

Insertion time

Insertion time is defined as the time from picking up the device to confirming successful placement (the appearance of the ETCO2 on the monitor screen).

Time frame: During the insertion of i-gel or LMA protector

Ease of insertion

Ease of insertion is defined as follows. Easy: requiring no additional maneuver, fair: requiring 1 additional maneuver, difficult: requiring more than 1 additional maneuver.

Time frame: During the insertion of i-gel or LMA protector

Ease of gastric tube insertion

Ease of garstic tube insertion is assessed as follows; easy, difficult, impossible.

Time frame: At 25 min after the insertion of i-gel or LMA protector

The accuracy of insertion location of the device in the oropharyngeal space

After insertion of the device, the insertion location is assessed using a fiberoptic bronchoscope; 4, only the vocal cords seen; 3, vocal cords and posterior part of the epiglottis seen; 2, vocal cords and anterior part of the epiglottis seen; 1, vocal cords not seen, but adequate ventilation.

Time frame: At 15 min after the insertion of i-gel or LMA protector

Data from ClinicalTrials.gov

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