A New Insertion Technique for Laryngeal Mask Airway
Condition: Airway Morbidity
Study type: Interventional

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.
    

Intervention name(s): Group 1 Classic; Group 2 pre-inflated; Group 3 ELL-PIC
Intervention type(s): Other; Other; Other
Intervention description(s): Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.; 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-PIC): Using the ELL-PIC technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Intubation; Airway; Laryngeal Mask Airway