Clinical trial NCT04501068: Evaluation of the Ambu® AuraGain in Ambulatory Surgery
Official title: Analysis of 150 Consecutive Uses of the Ambu® AuraGain Supraglottic Airway by One Anaesthetist in Ambulatory Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway
Keywords: Ambu® AuraGainTM
Second Generation Laryngeal Masks Airway
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for outpatient surgery. Patients who require the insertion of a supraglottic device as part of their anesthetic management.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the number of attempts to insert the Ambu® AuraGainTM supraglottic airway
timeFrame: The number of insertion attempts will be collected after anesthesia induction
measure: Evaluate the time to insert the Ambu® AuraGainTM supraglottic airway
timeFrame: The insertion time will be collected after anesthesia induction after administration of propofol
Secondary outcomes:
measure: Blood pressure during insertion of the Ambu® AuraGainTM supraglottic airway
timeFrame: At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway
measure: Heart rate during insertion of the Ambu® AuraGainTM supraglottic airway heart rate
timeFrame: At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway]
measure: BIS data
timeFrame: 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
measure: Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway.
timeFrame: The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be collected 10 minutes after the Ambu® AuraGainTM supraglottic airway will be inserted]
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon
Study officials:
affiliation: Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón
name: Javier Hortal, MD, PhD
role: STUDY_CHAIR
References:
citation: Shariffuddin II, Teoh WH, Tang E, Hashim N, Loh PS. Ambu(R) AuraGain versus LMA Supreme Second Seal: a randomised controlled trial comparing oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients. Anaesth Intensive Care. 2017 Mar;45(2):244-250. doi: 10.1177/0310057X1704500215.
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(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26.
citation: 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/s10877-016-9963-0. Epub 2016 Nov 26.
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(R) AuraGain laryngeal mask and LMA(R) Fastrach. Anaesth Intensive Care. 2018 Sep;46(5):474-479. doi: 10.1177/0310057X1804600508.