MedTrace Logo

A New Insertion Technique for Laryngeal Mask Airway

NCT01749033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2019-12-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Airway Morbidity

Interventions

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.

OTHER

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.

OTHER

Group 3 ELL-PIC

Group 3 (ELL-PIC): Using the ELL-PIC technique

Sponsors & Collaborators

Principal Investigators

  • David Walega, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749033 on ClinicalTrials.gov