A New Insertion Technique for Laryngeal Mask Airway
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Airway Management Laryngeal Masks |
Other: Group 1 Classic Other: Group 2 pre-inflated Other: Group 3 ELLIA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
| Official Title: | A New Insertion Technique for Laryngeal Mask Airway |
- Postoperative pharyngolaryngeal complications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The primary outcomes for this study will be postoperative pharyngolaryngeal complications including sore throat, dysphonia (difficult talking), and dysphagia (difficulty swallowing).
| Estimated Enrollment: | 450 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
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. |
|
Active Comparator: Group 2 pre inflated
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
|
Other: Group 2 pre-inflated
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
|
Active Comparator: Group 3 ELLIA technique
Group 3 (ELLIA): Using the ELLIA technique.
|
Other: Group 3 ELLIA
Group 3 (ELLIA): Using the ELLIA technique
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ASA I, II, III Age 18-70 General anesthetic for where LMA 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
Contacts and Locations| Contact: Ling Qun Hu, MD | 312-926-8373 | lhu2@northwestern.edu |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Ling Qun Hu, MD 312-926-8373 Lhu2@northwestern.edu | |
| Principal Investigator: | Ling Qun Hu, MD | Northwestern University |
More Information
No publications provided
| Responsible Party: | Ling Qun Hu, Principal Investigator, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01749033 History of Changes |
| Other Study ID Numbers: | STU00046964 |
| Study First Received: | December 11, 2012 |
| Last Updated: | December 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Northwestern University:
|
Endotracheal Intubation |
ClinicalTrials.gov processed this record on May 19, 2013