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
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.
Study Type
OBSERVATIONAL
Enrollment
150
Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia
Hospital Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario Gregorio Maranon
Madrid, Spain
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)
Time frame: 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)
Time frame: The insertion time will be collected after anesthesia induction after administration of propofol
Blood pressure during insertion of the Ambu® AuraGainTM supraglottic airway
Blood pressure in mmHg
Time frame: 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
Time frame: 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)
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be collected 10 minutes after the Ambu® AuraGainTM supraglottic airway will be inserted]