A New Insertion Technique for Laryngeal Mask Airway

Airway Morbidity Clinical Trial

Official title:

A New Insertion Technique for Laryngeal Mask Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749033
• Other study ID #: STU00046964
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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:

• 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

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Other:
• Group 1 Classic
Active Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
• 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.
• Group 3 ELL-PIC
Group 3 (ELL-PIC): Using the ELL-PIC technique

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Blood on LMA After Removal	Presence of blood immediately after the removal of the LMA after surgery.	Immediately after LMA removal