Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

Study Overview
=================
Brief 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: 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. 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. 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). Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube. 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. 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%) Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale

Official Title
-----------------
Comparison of the Ambu AuraGain vs. LMA Supreme in Paralysed Patients Undergoing Gynecologic Laparoscopic Surgery in the Trendelemburg Position

Conditions
-----------------
Laparoscopy, Airway Management, Supraglottic Airway Devices

Intervention / Treatment
-----------------
* Device: Ambu AuraGain evaluation
* Device: LMA Supreme evaluation
* Procedure: Laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients evaluated as eligible for a SGA ASA I-III Without criteria for difficult airway Body Mass Index ≤ 35 kg/m2 The patient has signed the Informed Consent The patient understands his or hers rights and consequences related to this investigation Exclusion Criteria: Planned operation time > 2 hours High risk of regurgitation Respiratory tract pathology Preoperative sore throat Patients with a known or predicted difficult airway Patients diagnosed with dementia or any mental handicaps Patient who has a guardian.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ambu AuraGain<br>Insertion of the supraglottic device and evaluation of its clinical performance | Device: Ambu AuraGain evaluation<br>* Evaluation of clinical performance in terms of Insertion, ventilation, position and complications<br>Procedure: Laparoscopic surgery<br>* Gynecologic laparoscopic surgery in the trendelemburg position<br>|
| Active Comparator: LMA Supreme<br>Insertion of the supraglottic device and evaluation of its clinical performance | Device: LMA Supreme evaluation<br>* Evaluation of clinical performance in terms of Insertion, ventilation, position and complications<br>Procedure: Laparoscopic surgery<br>* Gynecologic laparoscopic surgery in the trendelemburg position<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway seal pressure | Maximum airway pressure that the device can achieve without oropharyngeal leak of gas. | At 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of insertion of the device | Time needed to insert the device | Baseline | 
| Change in Quality of ventilation | number of manoeuvres/corrections required | At baseline and at 15, 30 and 60 minutes | 
| Endoscopic view of glottic structures | Assessment of alignment with the glottic inlet as: complete view of the vocal cords (I), epiglottis visible inside, but not causing any obstruction (II), epiglottis visible and causing obstruction (III) or glottis not identified (IV) | At 15 minutes | 
| Gastric tube insertion | Ease of passage of a gastric tube as: easy, difficult or impossible | At 5 minutes | 
| Incidence of perioperative complications | number of patients with adverse events: Airway obstruction, desaturation, Aspiration, oropharyngeal trauma, sore throat | 2 hours |