Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
Condition: Performance and Safety of an Airway Management Device
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators have performed a number of studies on novel airway devices, including an
      observational study on the performance of a new supraglottic airway named Baska mask. In this
      new proposed study the investigators would like to compare directly,in a randomized clinical
      trial, this device with the device the investigators routinely use - the single use laryngeal
      mask airway - LMA, in female patients undergoing general anaesthesia.

      This study will determine which device performs best, as measured by key parameters
      (insertion success rate, seal pressures, time to and ease of insertion, failure rate,
      complications etc) as regarding the performance and safety profile of the Baska mask and the
      LMA.

      The investigators have two study hypotheses, namely (1) non-inferiority of first placement
      attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA.

      A number of secondary endpoints will be monitored and analyzed (time to and ease of
      insertion, failure rate, complications etc).
    

Detailed description: 
      Airway management is essential component of the safe and efficient provision of general
      anaesthesia. Supraglottic airway devices have established place in the airway management.

      The Baska mask is a new supraglottic airway device. It bears many of the features of the
      industry standard - the laryngeal mask airway (LMA), with few potential improvements:

        -  The cuff is not pressurized thus reducing the risk of oropharyngeal tissue damage.

        -  Improved cuff seal during the inspiratory phase of positive pressure ventilation which
           may reduce leak and make ventilation more efficient.

        -  An improved system for drainage of oropharyngeal contents intended to reduce the rate of
           lung aspiration.

        -  The Baska mask is inserted in neutral head position thus reducing the need for neck
           manipulation.

        -  There is integrated bite-block to reduce the risk of patients biting and blocking the
           airway.

      The results from the observational study of the performance of the Baska mask are promising
      and the investigators feel a randomized comparative study against the gold standard device,
      the Laryngeal Mask Airway (LMA) is justified.

      This study is a randomized, single blinded, controlled clinical trial. The participants will
      be allocated to two groups, in which the investigators will use either a single use LMA
      device or the Baska mask (single use).

      Clinical Research Ethics Committee approval has been obtained. Suitable participants will be
      recruited after written informed consent and screened for inclusion and exclusion criteria.

      Standard anaesthetic preassessment and anaesthesia will be provided.

      Consenting patients will be randomly allocated to either of the 2 study groups.

      Protocol for airway size selection and attempts at placement will be followed.

      The investigators will monitor a number of parameters, including time and ease of insertion,
      airway seal pressure, airway leak, complications, haemodynamic and ventilatory parameters,
      ease of removal and other.

      Follow up will be performed.

      The investigators have two primary hypotheses:

        1. That the BASKA mask will have an insertion success rate that is no more than 20% less
           than that of the single use LMA device.

        2. That the seal pressure with the BASKA mask will be 40% higher than that of the single
           use LMA.

      In addition to the above the investigators will evaluate a number of secondary outcomes.
    

Intervention name(s): supraglottic airway placement and use
Intervention type(s): Device
Intervention description(s): The investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Baska mask; LMA; laryngeal mask airway; supraglottic airway device