Intubation, Endotracheal Clinical Trial
Official title:
The Ambu® Laryngeal Mask as an Intubation Conduit For Patients Undergoing Routine General Anesthesia
The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an intubation conduit for endotracheal intubation.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
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