Evaluation of the Ambu® AuraGain in Ambulatory Surgery

Completed

• Conditions: Airway

• Registration Number: NCT04501068
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief Summary

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

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Heart rate during insertion of the Ambu® AuraGainTM supraglottic airway heart rate	At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway]	Heart rate in beep per minute
BIS data	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	Bis data: number from 100 (awake) to 40-45 (anesthetic status)
Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway.	The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be collected 10 minutes after the Ambu® AuraGainTM supraglottic airway will be inserted]	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)
Blood pressure during insertion of the Ambu® AuraGainTM supraglottic airway	At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway	Blood pressure in mmHg

Trial Locations

Locations (2)

Hospital Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain