Multicenter Study of the Protector Laryngeal Mask
Condition: Airway
Study type: Observational

Summary: 
      The study was designed to evaluate the success rate, time of insertion, sealing efficacy and
      security of the Protector Laryngeal Mask, a new second generation disposable supraglottic
      airway device, in patients undergoing elective surgery.
    

Detailed description: 
      Laryngeal masks (LM) and supraglottic devices (SGD), in all their different forms, have
      become an authentic innovation in airway management especially in day surgery.

      LMA Protector (Teleflex Medical, Athlone, Ireland) is a new disposable SGD currently
      available for anaesthetic practice. It is made of silicone (with no latex in its composition)
      and shares some of the characteristics of the second generation SGDs (as the presence of a
      gastric access channel); however, it has an additional drainage channel, both channels
      terminate distally in a camera behind the mask cuff. The presence of two drainage channels
      ("male" and "female") increases the patient safety against regurgitation, both of distal
      gastric content and secretions located in the oropharyngeal region. The gastric access
      channel called "female" also allows the insertion of a nasogastric tube if required. These
      drainage channels are useful for diagnosing the correct position of the mask, since the
      observation of leaks or gas through it can help diagnose a displacement the mask.

      LMA Protector is designed with a preformed anatomic curve, and the airway conduct has an
      elliptical cross section, which ends distally in the mask. This design follows the anatomy of
      the human airway, which facilitates the insertion of the device. The softness of the mask
      material allows easy insertion.

      Doubts regarding the transmission of infectious diseases with reusable devices makes
      disposable devices such as LMA Protector, one of the most interesting devices for use in
      anaesthetic procedures that are usually performed with SGD.

      Its characteristics in the design, composition by a smooth and atraumatic material, the
      presence of two gastric drainage accesses, with potential improved patient safety and its
      characteristic of being disposable suggests a significant expansion of its use in the coming
      years .

      In contrast to other SGDs that have been evaluated extensively, to date there are no large
      clinical studies showing its suitably and performance in a daily clinical scenario.
    

Intervention name(s): Protector Laryngeal Mask airway
Intervention type(s): Device
Intervention description(s): Evaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing surgery procedures in any of the collaborating centers of the study
        that fulfill the inclusion and exclusion criteria described below.
      
Keywords: LMA Protector; Second Generation Laryngeal Masks; Airway; Dual Gastric Acces; Teleflex; Supraglottic Devices; Ambulatory Surgery