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A New Insertion Technique for Laryngeal Mask Airway

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Ling Qun Hu, Northwestern University
ClinicalTrials.gov Identifier:
NCT01749033
First received: December 11, 2012
Last updated: May 9, 2014
Last verified: May 2014
  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 Morbidity
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

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Number of subjects who present with 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 to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA (American Society of Anesthesiologists patient fitness category) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749033

Contacts
Contact: Ling Qun Hu, MD 312-926-8373 lhu2@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Ling Qun Hu, MD    312-926-8373    Lhu2@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
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: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Intubation
Airway
Laryngeal Mask Airway

ClinicalTrials.gov processed this record on November 27, 2014