Evaluation of the Ambu® AuraGain in Ambulatory Surgery

NCT04501068 | Completed

• 1 other identifier: MULTIAURAGAIN
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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

Conditions

Airway

Keywords

Ambu® AuraGainTM; Second Generation Laryngeal Masks Airway

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• 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]

• 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

• 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]

Study Arms (1)

Ambu AuraGain

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

Interventions

Ambu® AuraGainTM DEVICE

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

Ambu AuraGain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing surgery procedures in ambulatory surgery usually performed with supraglottic devices.
• ASA physical status I-III patients
• Age 18-no limit

You may not qualify if:

• Patients with known difficult airway
• Patients with increased risk of aspiration
• Patient refusal to participate in the study

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (2)

Hospital Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Gregorio Maranon

Madrid, Spain

Location

Related Publications (4)

• 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.

  PMID: 28267947 RESULT

• 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.

  PMID: 29582360 RESULT

• 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.

  PMID: 27889843 RESULT

• 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.

  PMID: 30189821 RESULT

Study Officials

• Javier Hortal, MD, PhD

  Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 6, 2020
• Study Start: January 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)