Evaluation of the Ambu® AuraGain in Ambulatory Surgery

Airway Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501068
• Other study ID #: MULTIAURAGAIN
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway

Intervention

Device:
• Ambu® AuraGainTM
Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia

Locations

Country	Name	City	State
Spain	Hospital Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Lopez AM, Agusti M, Gambus P, Pons M, Anglada T, Valero R. A randomized comparison of the Ambu AuraGain versus the LMA supreme in patients undergoing gynaecologic laparoscopic surgery. J Clin Monit Comput. 2017 Dec;31(6):1255-1262. doi: 10.1007/s10877-016 — View Citation

Preece G, Ng I, Lee K, Mezzavia P, Krieser R, Williams DL, Stewart O, Segal R. A randomised controlled trial comparing fibreoptic-guided tracheal intubation through two supraglottic devices: Ambu® AuraGain™ laryngeal mask and LMA® Fastrach™. Anaesth Inten — View Citation

Shariffuddin II, Teoh WH, Tang E, Hashim N, Loh PS. Ambu® AuraGain™ versus LMA Supreme™ Second Seal™: a randomised controlled trial comparing oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients. Anaesth Intensi — View Citation

Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu® AuraGain™ and the LMA® Supreme™ supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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]
Secondary	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
Secondary	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]