Evaluation of the Ambu® AuraGain in Ambulatory Surgery

Study Overview
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Brief Summary
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The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Ambu® AuraGain in patients undergoing ambulatory surgery by one anesthetist

Detailed Description
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Supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery. The Ambu® AuraGainTM (Ambu A/S, Ballerup, Denmark) is a new single-use, anatomically curved supraglottic airway with an integrated gastric access port designed to provide functional separation of the respiratory and digestive tracts allowing the exit of gastric contents and the passage of a gastric tube to manage gastric contents. Its characteristics in the design, composition by a smooth and atraumatic material, the presence of the gastric drainage access, with potential improved patient safety and its characteristic of being disposable, suggests a significant expansion of its use in the coming years. The series in the literature reporting performance or safety of use of the Ambu® AuraGainTM come from studies on selected cases and in certain surgical procedures. However, there are limited studies that have evaluated the efficacy of the device in routine clinical practice in patients intervened in ambulatory surgery and performed by a single investigator.

Official Title
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Analysis of 150 Consecutive Uses of the Ambu® AuraGain Supraglottic Airway by One Anaesthetist in Ambulatory Surgery

Conditions
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Airway

Intervention / Treatment
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* Device: Ambu® AuraGainTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing surgery procedures in ambulatory surgery usually performed with supraglottic devices. ASA physical status I-III patients Age 18-no limit Exclusion Criteria: Patients with known difficult airway Patients with increased risk of aspiration Patient refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ambu AuraGain<br>Ambu® AuraGainTM Patients undergoing anesthesia in which airway management includes a Ambu® AuraGainTM supraglottic airway and fulfill the inclusion criteria of the study. | Device: Ambu® AuraGainTM<br>* Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the number of attempts to insert the Ambu® AuraGainTM supraglottic airway | Insertion attempts (in numbers) From picking up the Ambu® AuraGainTM supraglottic airway until the mask is placed into the patient mouth. (in numbers) | The number of insertion attempts will be collected after anesthesia induction | 
| Evaluate the time to insert the Ambu® AuraGainTM supraglottic airway | The time from picking up the Ambu® AuraGainTM supraglottic airway until the cuff was inflated. (in seconds) | The insertion time will be collected after anesthesia induction after administration of propofol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure during insertion of the Ambu® AuraGainTM supraglottic airway | Blood pressure in mmHg | At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway | 
| Heart rate during insertion of the Ambu® AuraGainTM supraglottic airway heart rate | Heart rate in beep per minute | At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway] | 
| BIS data | Bis data: number from 100 (awake) to 40-45 (anesthetic status) | At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway (To evaluate the evolution of BIS values during insertion of the Ambu® AuraGainTM supraglottic airway | 
| Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway. | The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be determined with an intracuff pressure of 60 cm H2O by closing the expiratory valve of the breathing circle circuit at a fixed gas flow of 3 L/min and noting the pressure at which an oropharyngeal leak occurs. (in cm H2O) | The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be collected 10 minutes after the Ambu® AuraGainTM supraglottic airway will be inserted] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambu® AuraGainTM, Second Generation Laryngeal Masks Airway