CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 450 enrolled
Drug / intervention
Group 1 Classic +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01749033
NCT01749033N/ACompleted

A New Insertion Technique for Laryngeal Mask Airway

Northwestern University·interventional·Posted Dec 13, 2012·Updated Dec 17, 2019

In Brief

A clinical study evaluating Group 1 Classic, Group 2 pre-inflated, and 1 other intervention for Airway Morbidity. Completed, enrolled 450 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2012
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.6 years ago

Interventions

Group 1 Classicother

Active Comparator: Group 1 classic Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.

Group 2 pre-inflatedother

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-PICother

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