Clinical trial NCT01749033: A New Insertion Technique for Laryngeal Mask Airway
Official title: A New Insertion Technique for Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Keywords: Intubation
Airway
Laryngeal Mask Airway
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Number of Subjects Who Present With Postoperative Sore Throat
timeFrame: 24 hours
measure: The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia
timeFrame: 24 hours
measure: The Primary Outcomes for This Study Will be Postoperative Dysphagia.
timeFrame: 24 hours
measure: The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
timeFrame: 24 hours
Secondary outcomes:
measure: Severity of Sore Throat
timeFrame: 24 hours
measure: Blood on LMA After Removal
timeFrame: Immediately after LMA removal
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: David Walega, MD
role: STUDY_DIRECTOR
References:
citation: Hu LQ, Leavitt OS, Malwitz C, Kim H, Doty RA Jr, McCarthy RJ. Comparison of laryngeal mask airway insertion methods, including the external larynx lift with pre-inflated cuff, on postoperative pharyngolaryngeal complications: A randomised clinical trial. Eur J Anaesthesiol. 2017 Jul;34(7):448-455. doi: 10.1097/EJA.0000000000000650.