A New Insertion Technique for Laryngeal Mask Airway
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About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
450 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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