A Randomised Controlled Trial to Compare Two Supraglottic Airway Devices (Ambu AuraGain vs Air Q-3) in Terms of Performance Characteristics.

NCT06914453 | Completed DMC

• 1 other identifier: UMalaya (MREC 2024426-13665)
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A supraglottic airway device (SAD) functions as a temporary device to maintain the patency of airway during the administration of anaesthesia. The Ambu AuraGain (Ambu, Ballerup, Denmark) is a second generation SAD, since introduced in 2014, has been widely used in clinical practice. The Ambu AuraGain is an anatomically curved, single-use supraglottic airway device that features a port for orogastric tube insertion and it is a conduit for intubation as well. It is also associated with fast insertion times and high seal pressures. The Air-Q3, on the other hand, is relatively new SAD, however rather similar to Ambu AuraGain, it is also anatomically curved with a built-up mask heel for improved seal and it serves as a conduit for intubation as it features a unique endotracheal tube ramp and epiglottis elevator which aids in fast easy and safe intubation. It also features a port for orogastric tube insertion. Given the relatively recent introduction of the Air-Q3 into the market, there exists a paucity of comprehensive data regarding its efficacy. Meanwhile, the Ambu AuraGain stands as one of the most frequently utilised SAD, especially in our centre. This randomized controlled trial aims to compare the performance characteristics of the Ambu AuraGain and Air Q-3 in 90 patients undergoing surgery under general anaesthesia. The primary objective is to evaluate oropharyngeal leak pressure (OLP), while secondary objectives includes time to insertion, first-pass success rate, ease of orogastric tube (OGT) insertion, laryngeal alignment using a fiberoptic scope, and incidence of postoperative complications.

Conditions

Oropharyngeal Leak Pressure; Supraglottic Airway; Elective Surgery; General Anaesthesia

Keywords

Ambu AuraGain; Supraglottic Airway Device; General Anaesthesia; Oropharyngeal leak pressure; Laryngeal Alignment; Air-Q3

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure (OLP) of the Air-Q3 and Ambu AuraGain supraglottic airway device

  After induction of general anaesthesia, either one supraglottic airway device will be inserted, Oropharyngeal leak pressure will be determined by transiently halting ventilation and closing the adjustable pressure limiting valve up to 30cmH2O with a fresh gas flow of 3L/min. The airway pressure at equilibrium or when audible air leak is heard from the throat is recorded.

  After induction of general anaesthesia until successful insertion of supraglottic airway device

Secondary Outcomes (3)

• Other performance characteristics in terms of time to insertion, first pass success rate, ease of orogastric tube (OGT) insertion.

  After induction of anaesthesia until comfirmation of correct orogastric tube placement will be established through aspiration of gastric contents or epigastric auscultation

• Laryngeal alignment using fibreoptic scope by employing the standardised scale developed by Brimacombe

  After insertion of supraglottic airway device till performing fibreoptic scope assessment

• Incidence of complications of using both SADs such as post operative sore throat

  From extubation until full consciousness in recovery area

Study Arms (2)

Ambu AuraGain

ACTIVE COMPARATOR

Patients in this group, once under general anaesthesia, will have this supraglottic airway device inserted to maintain airway patency and maintenance of general anaesthesia.

Device: Ambu AuraGain Supraglottic Airway Device

Air Q-3

ACTIVE COMPARATOR

Patients in this group, once under general anaesthesia, will have this supraglottic airway device inserted to maintain airway patency and maintenance of general anaesthesia.

Device: Air Q-3 Supraglottic Airway Device

Interventions

Air Q-3 Supraglottic Airway Device DEVICE

Oropharyngeal leak pressure and other performance characteristics including time to insertion, first-pass success rate, ease of orogastric tube (OGT) insertion, laryngeal alignment using a fiberoptic scope, and incidence of postoperative sore throat.

Air Q-3

Ambu AuraGain Supraglottic Airway Device DEVICE

Oropharyngeal Leak Pressure and other performance characteristics including time to insertion, first-pass success rate, ease of orogastric tube (OGT) insertion, laryngeal alignment using a fiberoptic scope, and incidence of postoperative sore throat.

Ambu AuraGain

Eligibility Criteria

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

You may qualify if:

• Adult patients (age 18 to 65 years) of either sex, who are scheduled for an elective surgery under general anaesthesia
• Patients with ASA physical status of I or II.

You may not qualify if:

• Patients with anticipated difficult airway (Airway Difficulty Score \>8)
• Patients with high risk of aspiration and regurgitation
• Patients with body mass index (BMI) \> 40kg/m2
• Patients who exhibit evidence of upper respiratory tract infection
• Patients with history of radiotherapy to the neck
• Patients who are pregnant
• Patients who are unable or unwilling to consent for the study
• Patients who are mentally challenged and unable to understand the study instructions
• Planned operating time more than 4 hours

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Department of Anaesthesiology, Faculty of Medicine

Kuala Lumpur, Selangor, 50603, Malaysia

Location

Related Publications (7)

• Gupta R, Mahajan R, Jatinder M, Gulati S, Mehta A, Nazir R. A comparison between ProSeal laryngeal mask airway and Air-Q Blocker in patients undergoing elective laparoscopic cholecystectomy. J Anaesthesiol Clin Pharmacol. 2019 Jul-Sep;35(3):340-347. doi: 10.4103/joacp.JOACP_397_17.

  PMID: 31543582 BACKGROUND

• 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 BACKGROUND

• Singh A, Bhalotra AR, Anand R. A comparative evaluation of ProSeal laryngeal mask airway, I-gel and Supreme laryngeal mask airway in adult patients undergoing elective surgery: A randomised trial. Indian J Anaesth. 2018 Nov;62(11):858-864. doi: 10.4103/ija.IJA_153_18.

  PMID: 30532321 BACKGROUND

• 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 BACKGROUND

• Che Omar S, Hardy Mohamad Zaini R, Fui Wong T, Nazaruddin W Hassan WM. Comparison of the Air-Q intubating laryngeal mask airway and the Ambu AuraGain laryngeal mask airway as a conduit for fibreoptic assisted endotracheal intubation for simulated cervical spine injury. Anaesthesiol Intensive Ther. 2021;53(3):241-245. doi: 10.5114/ait.2021.105759.

  PMID: 34006053 BACKGROUND

• Jindal S, Mittal A, Anand LK, Singh M, Kapoor D. Comparative evaluation of Air-Q blocker and Proseal laryngeal mask airway in patients undergoing elective surgery under general anaesthesia: A randomised controlled trial. Indian J Anaesth. 2021 Mar;65(Suppl 1):S20-S26. doi: 10.4103/ija.IJA_1254_20. Epub 2021 Mar 20.

  PMID: 33814586 BACKGROUND

• Brimacombe J, Berry A. A proposed fiber-optic scoring system to standardize the assessment of laryngeal mask airway position. Anesth Analg. 1993 Feb;76(2):457. No abstract available.

  PMID: 8424538 BACKGROUND

Related Links

• Ambu AuraGain Official Website
• Air Q-3 Official Website

Study Officials

• Ina Ismiarti Shariffuddin, Clinical Professor

  Univerisity Malaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Two Types of Supraglottic Airway Devices (Ambu AuraGain and Air Q-3) are involved. A total of 90 patients will be randomised using a computer-generated randomisation table to either receive Air-Q3 or Ambu AuraGain. 45 patients in each group

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: July 26, 2024
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)