Ambu® Laryngeal Mask as an Intubation Conduit
Condition: Intubation, Endotracheal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an
      intubation conduit for endotracheal intubation.
    

Detailed description: 
      The laryngeal mask airway (LMA) is an established supra-glottic device that provides better
      ventilation than traditional mask ventilation and is less invasive than endotracheal
      intubation. Being less invasive, it is commonly used for short elective surgical procedures.
      Its ability to be both easily and rapidly inserted also makes it useful as a rescue device in
      difficult and failed intubations. Being a supra-glottic device, the LMA does not protect
      patients from regurgitation and aspiration. Additionally, patients requiring alternative
      positions, such as prone or lateral, or those having surgery in the neck/head area are
      contra-indicated for LMA use due to risk of possible movement of the LMA, and therefore
      possible loss of airway patency. Thus, the LMA can be utilized as an intermediary method of
      airway management to endotracheal intubation.

      The manufacturer of the reusable LMA-ClassicTM states that "the success rate of intubation
      through the standard LMA-ClassicTM is highly variable (30-93%)," whereas the success rate of
      the disposable version, LMA-UniqueTM, has been found to be only 21%1. An LMA specifically
      designed for intubation now exists and improves the success rate of intubation. The reusable
      LMA-FastrachTM or Intubating-LMATM (ILMA) is a rigid and anatomically curved airway tube. It
      is wide enough to accommodate 8.0 mm cuffed endotracheal tubes. Attached to the ILMA is a
      rigid handle to aid in one-handed insertion, removal, and adjustment. Success rates for
      intubating through the ILMA are 96.5% when inserted blindly and 100% with fiberoptic
      guidance2. No disposable version of the ILMA presently exists.

      The Ambu® Laryngeal Mask (ALMA) is a new disposable laryngeal mask with an anatomical curve
      similar to the ILMA. The reasons for the use of disposable products can be many and varied.
      The residual risk of the transmission of germs and protein particles represents one
      indication. If supra-glottic airway devices are used electively or in emergencies, e.g. for
      HIV-positive patients or those infected with Creutzfeldt-Jacob disease, reuse of the products
      is not desirable. Disposable products, on the other hand, offer the benefit that the
      transmission of germs is avoided, and at the same time offer considerable economic advantages
      due to the much lower price of the product. The disposable ALMA has been proven as an
      effective and safe supra-glottic airway device3. Upon fiberoptic visualization through its
      shaft, the glottis was visualized 91.5% of the time, indicating that this device may be used
      as an intubation conduit. The purpose of this study is to determine if the ALMA is also safe
      and effective as an intubating conduit. The hypothesis is that the ALMA will perform as well
      as, if not better than the LMA-UniqueTM.
    

Intervention name(s): Ambu Laryngeal Mask; Aintree Exchange Catheter; Laryngeal Mask Airway
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: Endotracheal Intubation; Supraglottic Airway