A New Insertion Technique for Laryngeal Mask Airway

Study Overview
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Brief Summary
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A laryngeal mask airway (LMA) is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient's lungs while anesthetized. It is similar to an endotracheal tube (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the working end of the LMA, which rests in the patient's throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the ELLIA method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.

Detailed Description
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The LMA will be inserted based on one of three methods randomly assigned to each patient. The ELLIA technique involves gently lifting the patient's laryngeal structures (throat) while placing the LMA to oppose the force of gravity. Whereas the traditional method of placement involves guiding the LMA through the pharynx with a finger inserted into the pharynx, the ELLIA method avoids this step. General anesthesia will be maintained at the discretion of the Anesthesiologist throughout the surgical procedure. At the end of the case, as would normally occur, the LMA will be removed from the patient's airway and the patient will be taken to the PACU, where he or she will be cared for as usual. At one and two hours postoperatively, blinded research assistants will assess the patient for sore throat, hoarse voice, and difficulty swallowing. Finally, at 24 hours the patient will receive a telephone call from a blinded research assistant assessing for the same outcomes. These data will be collected and presented.

Official Title
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A New Insertion Technique for Laryngeal Mask Airway

Conditions
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Airway Morbidity

Intervention / Treatment
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* Other: Group 1 Classic
* Other: Group 2 pre-inflated
* Other: Group 3 ELL-PIC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American Society of Anesthesiologists patient fitness category) I, II, III Age 18-90 General anesthetic for where LMA (Laryngeal Mask Airway) placement is not contraindicated will be included Exclusion Criteria: Small mouth opening Preoperative sore throat/dysphagia/dysphonia Patients at increased risk for aspiration Morbid obesity BMI > 40 Untreated chronic GERD Pregnancy Suspected supraglottic abnormalities N2O use Need for oral-pharyngeal suctioning Undergoing oral and nasal surgery Intubation or any oral instrumental manipulations other than LMA placements intraoperatively or postoperatively

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 classic<br>Group 1 Using the classic inserting technique and completely deflated LMA (Laryngeal Mask Airway)recommended in the LMA manual. | Other: Group 1 Classic<br>* Active Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.<br>|
| Active Comparator: Group 2 pre inflated<br>Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer | Other: Group 2 pre-inflated<br>* Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer.<br>|
| Active Comparator: Group 3 ELL-PIC technique<br>Group 3 (ELL-PIC): Using the ELL-PIC technique. | Other: Group 3 ELL-PIC<br>* Group 3 (ELL-PIC): Using the ELL-PIC technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Present With Postoperative Sore Throat | The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant. | 24 hours | 
| The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia | The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement. | 24 hours | 
| The Primary Outcomes for This Study Will be Postoperative Dysphagia. | The primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant. | 24 hours | 
| The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia. | The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Sore Throat | Severity of sore throat 24 hours after airway placement on a 11 point scale of 0-10 ( 0 equals no pain and 10 equals worst pain ever) per recovery hour. Low pain = 0 high pain= 500 composite score (0 to 11 points per hour x 24 hours) | 24 hours | 
| Blood on LMA After Removal | Presence of blood immediately after the removal of the LMA after surgery. | Immediately after LMA removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Airway, Laryngeal Mask Airway