A New Insertion Technique for Laryngeal Mask Airway

Not Applicable

Completed

Interventions: Other: Group 3 ELL-PIC
Other: Group 1 Classic
Other: Group 2 pre-inflated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group 3 ELL-PIC technique	Group 3 ELL-PIC	Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 1 classic	Group 1 Classic	Group 1 Using the classic inserting technique and completely deflated LMA (Laryngeal Mask Airway)recommended in the LMA manual.
Group 2 pre inflated	Group 2 pre-inflated	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

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Present With Postoperative Sore Throat	24 hours	The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.
The Primary Outcomes for This Study Will be Postoperative Dysphagia.	24 hours	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.
The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia	24 hours	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.
The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.	24 hours	The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.

Secondary Outcome Measures

Name	Time	Method
Blood on LMA After Removal	Immediately after LMA removal	Presence of blood immediately after the removal of the LMA after surgery.
Severity of Sore Throat	24 hours	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)

Locations (1): Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States