Comparison of the LMA Protector and the I-gel

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the LMA Protector and the I-gel in Anesthetized Patients.

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Device: I-gel
* Device: Laryngeal mask airway protector


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I-gel group<br>After the induction of anesthesia, I-gel is inserted into the oropharyngeal space. | Device: I-gel<br>* After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.<br>|
| Experimental: LMA protector group<br>After the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space. | Device: Laryngeal mask airway protector<br>* After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 5 min after the insertion of i-gel or LMA protector | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of insertion attempt for the successful placement | The numbers of insertion attempt for successful placement are counted. | 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). | 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. | 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. | 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. | At 15 min after the insertion of i-gel or LMA protector | 
| Blood staining on the i-gel or LMA protector | After removal of the device, the presence of blood staining on the device is checked. | Immediately after removal of i-gel or LMA protector | 
| The incidence and severity of postoperative sore throat | Postoperative sore throat is assessed using a numerical rating scale (0-100 point). | At 1 and 24 h after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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I-gel, Laryngeal mask airway protector