Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery
Condition: Laparoscopy; Airway Management; Supraglottic Airway Devices
Study type: Interventional

Summary: 
      The aim of the study is to compare the performance of two supraglottic airway devices (SGA),
      the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic
      laparoscopy in the trendelemburg position.

      Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion,
      quality of ventilation, endoscopic view of the glottis, gastric tube passage and
      complications.
    

Detailed description: 
      The patients are randomly assigned to 2 groups:

        -  Group 1: Ambu AuraGain.

        -  Group 2: LMA Supreme, Teleflex

      Procedure:

      The investigation protocol contains the following sections:

        1. Induction of anaesthesia. Intravenous infusion of remifentanil and propofol targeting
           the effect site (2-4 ng/ml and 4-6 µg/ml respectively). No muscle relaxant will be used
           for insertion of the SGA. Rocuronium 0.2 mg/Kg will be administered before initiation of
           pneumoperitoneum.

        2. Insertion of the SGAs. The size of the SGA device used is based on the manufacturers'
           recommendations. All devices are deflated a lubricated prior to use. Once inserted, the
           cuff is be inflated with a manometer up to 60 cm H20 Position of the device is adjusted
           if needed. Data recorded: size of SGA, time an number of attempts.

        3. Fibreoptic evaluation of the SGAs anatomical position: complete view of the vocal cords
           (I), epiglottis visible inside, but not causing obstruction (II), epiglottis visible and
           obstructing the glottic inlet (III), or glottic structures not identified (IV).

        4. Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube.

        5. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and
           at 15, 30 and 60 minutes. The maximum pressure allowed is 40 cm H2O.

        6. Ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60
           minutes.

           Perioperative complications: Hiccup, gastric distension, regurgitation / Aspiration,
           airway obstruction, laryngospasm, dental, mucosal or tongue injury, hypoxia (SpO2 < 92%)

        7. Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative
           complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale
    

Intervention name(s): Ambu AuraGain evaluation; LMA Supreme evaluation; Laparoscopic surgery
Intervention type(s): Device; Device; Procedure
Intervention description(s): Evaluation of clinical performance in terms of Insertion, ventilation, position and complications; Evaluation of clinical performance in terms of Insertion, ventilation, position and complications; Gynecologic laparoscopic surgery in the trendelemburg position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment