Oropharyngeal Leak PressureNCT06914453
A Randomised Controlled Trial to Compare Two Supraglottic Airway Devices (Ambu AuraGain vs Air Q-3) in Terms of Performance Characteristics.
A study testing Air Q-3 Supraglottic Airway Device and Ambu AuraGain Supraglottic Airway Device in people with Oropharyngeal Leak Pressure and Supraglottic Airway, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Leak Pressure, Supraglottic Airway, Elective Surgery
- What is being tested?
- Air Q-3 Supraglottic Airway Device and Ambu AuraGain Supraglottic Airway Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Jul 2024to 24 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Department of Anaesthesiology, Faculty of Medicine
Kuala Lumpur, Selangor, 50603
About this study
Official title: A Comparative Study of Air-Q3 and Ambu AuraGain Supraglottic Airway Device in Patients Undergoing Elective Surgery Under General Anaesthesia: A Randomised Controlled Trial
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.
Read the detailed description
Preoperative assessment, encompassing history taking, physical examination, laboratory investigation, and a comprehensive explanation of the study, will be conducted the day prior to surgery. Patients will be instructed to fast for 6 hours for solid foods and 2 hours for clear fluids before elective surgery.
Patients will be randomly allocated to either the Air-Q3 group (n = 45) or the Ambu AuraGain group (n = 45) using a computer-generated randomization table. After recruitment, the enrolling investigator opens the sealed opaque envelopes that concealed group allocation. Patients will be blinded to their group allocation. Patients will not receive any premedication and will be positioned supine on the operating table, head in neutral position, rested on a gel head ring. Standard monitoring including basic physiological variables, including electrocardiography, pulse oximetry, non-invasive blood pressure monitoring, and end-tidal oxygen measurement using a circle circuit ventilator (Datex Ohmeda, Aespire, Marquet), will be performed prior to anaesthesia induction.
Following establishment of intravenous access, a standard anaesthesia induction protocol will be followed, involving preoxygenation with 100% inspired oxygen for 3 minutes, intravenous administration of Fentanyl (1-2mcg/kg), and Propofol (2-3mg/kg) until loss of consciousness. Subsequently, either the Air-Q3 or Ambu AuraGain will be lubricated and prepared according to manufacturers' recommendations. The airway device will be inserted when the jaw is sufficiently relaxed. The cuff of each device will be inflated with air to a final cuff pressure of 60cmH20. The cuff pressure is measured by a handheld manometer, The airway device insertions will be performed by experienced staff anaesthesiologists with more than ten years experience with supraglottic airway management, who had performed at least 10 Air-Q3 insertions prior to trial commencement.
SAD size selection will adhere to manufacturers' recommendations based on the patient's ideal body weight. Insertion time will be recorded from facemask removal until the presence of square wave capnography tracing. The presence of square wave capnography tracing denotes successful establishment of effective ventilation. Otherwise, the device will be removed completely for another insertion attempt. Failure to insert the SAD after two attempts will be deemed a failure.
After successful insertion of the airway device, it will be secured with tape over the patient's check. A gel plug is applied to the orogastric port and a suprasternal notch test (gentle tapping over the suprasternal notch results in the gel to pulsate, confirming tip location behind the cricoid cartilage) will be done to confirm placement. A 14 French gauge gastric tube, pre lubricated with a water soluble lubricant will be inserted through the nasogastric port for both devices. The ease of insertion will be graded from 1 to 3 (1 = easy, 2 = difficult, 3 = impossible). After successful insertion of the airway device, it will be secured with tape over the patient's check. A gel plug is applied to the orogastric port and a suprasternal notch test (gentle tapping over the suprasternal notch results in the gel to pulsate, confirming tip location behind the cricoid cartilage) will be done to confirm placement. A 14 French gauge gastric tube, pre lubricated with a water soluble lubricant will be inserted through the nasogastric port for both devices. The ease of insertion will be graded from 1 to 3 (1 = easy, 2 = difficult, 3 = impossible). Confirmation of correct orogastric tube placement will be established through aspiration of gastric contents or epigastric auscultation.
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.
Following successful SAD insertion, fibreoptic scope assessment will be conducted to evaluate LMA placement, graded based on the standardized scale by Brimacombe:
- Vocal cords not seen
- Vocal cords plus anterior epiglottis visible
- Vocal cords plus posterior epiglottis visible
- Only vocal cords visible Maintenance of general anaesthesia will be with sevoflurane with minimum alveolar concentration 1 - 2 in an oxygen-air mixture.
Postoperatively, patients will be monitored in the recovery room, with physiological variables including non-invasive blood pressure, heart rate, pulse oximetry, and respiratory rate continuously monitored. Upon full consciousness and recovery, a blinded investigator will assess for the presence of sore throat.
- Being tested
- Air Q-3 Supraglottic Airway Device, Ambu AuraGain Supraglottic Airway Device
- Keywords
- Ambu AuraGain, Supraglottic Airway Device, General Anaesthesia, Oropharyngeal leak pressure, Laryngeal Alignment, Air-Q3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Q-3 Supraglottic Airway DeviceDevice
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 Supraglottic Airway DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Air Q-3 Supraglottic Airway Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Time of insertion will be recorded during the insertion of the airway device, the number of attempts to successful insertion will also be recorded. The ease of insertion of gastric tube will be graded from 1 to 3 (1 = easy, 2 = difficult, 3 = impossible).
Measured: 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
Following successful SAD insertion, fibreoptic scope assessment will be conducted to evaluate LMA placement, graded based on the standardized scale by Brimacombe:
- Vocal cords not seen
- Vocal cords plus anterior epiglottis visible
- Vocal cords plus posterior epiglottis visible
- Only vocal cords visible
Measured: After insertion of supraglottic airway device till performing fibreoptic scope assessment
Incidence of complications of using both SADs such as post operative sore throat
Post extubation, patient will be assessed for presence of sore throat
Measured: From extubation until full consciousness in recovery area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start26 Jul 2024
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal Leak PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Shu Ren, University of Malaya
- Investigators
- Ina Ismiarti Shariffuddin, Clinical Professor, Study director, Univerisity Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914453
- Sponsor's protocol ID
- UMalaya (MREC 2024426-13665)
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31543582Preece 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.
PubMed 30189821Singh 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.
PubMed 30532321Shariffuddin 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.
PubMed 28267947Che 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.
PubMed 34006053Jindal 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.
PubMed 33814586Brimacombe 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.
PubMed 8424538
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Air-Q3 and Ambu AuraGain Supraglottic Airway Device in Patients Undergoing Elective Surgery Under General Anaesthesia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06914453
- Acronym / sponsor ID
- UMalaya (MREC 2024426-13665)
- Keywords
- Ambu AuraGain, Supraglottic Airway Device, General Anaesthesia, Oropharyngeal leak pressure, Laryngeal Alignment, Air-Q3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preoperative assessment, encompassing history taking, physical examination, laboratory investigation, and a comprehensive explanation of the study, will be conducted the day prior to surgery. Patients will be instructed to fast for 6 hours for solid foods and 2 hours for clear fluids before elective surgery.
Patients will be randomly allocated to either the Air-Q3 group (n = 45) or the Ambu AuraGain group (n = 45) using a computer-generated randomization table. After recruitment, the enrolling investigator opens the sealed opaque envelopes that concealed group allocation. Patients will be blinded to their group allocation. Patients will not receive any premedication and will be positioned supine on the operating table, head in neutral position, rested on a gel head ring. Standard monitoring including basic physiological variables, including electrocardiography, pulse oximetry, non-invasive blood pressure monitoring, and end-tidal oxygen measurement using a circle circuit ventilator (Datex Ohmeda, Aespire, Marquet), will be performed prior to anaesthesia induction.
Following establishment of intravenous access, a standard anaesthesia induction protocol will be followed, involving preoxygenation with 100% inspired oxygen for 3 minutes, intravenous administration of Fentanyl (1-2mcg/kg), and Propofol (2-3mg/kg) until loss of consciousness. Subsequently, either the Air-Q3 or Ambu AuraGain will be lubricated and prepared according to manufacturers' recommendations. The airway device will be inserted when the jaw is sufficiently relaxed. The cuff of each device will be inflated with air to a final cuff pressure of 60cmH20. The cuff pressure is measured by a handheld manometer, The airway device insertions will be performed by experienced staff anaesthesiologists with more than ten years experience with supraglottic airway management, who had performed at least 10 Air-Q3 insertions prior to trial commencement.
SAD size selection will adhere to manufacturers' recommendations based on the patient's ideal body weight. Insertion time will be recorded from facemask removal until the presence of square wave capnography tracing. The presence of square wave capnography tracing denotes successful establishment of effective ventilation. Otherwise, the device will be removed completely for another insertion attempt. Failure to insert the SAD after two attempts will be deemed a failure.
After successful insertion of the airway device, it will be secured with tape over the patient's check. A gel plug is applied to the orogastric port and a suprasternal notch test (gentle tapping over the suprasternal notch results in the gel to pulsate, confirming tip location behind the cricoid cartilage) will be done to confirm placement. A 14 French gauge gastric tube, pre lubricated with a water soluble lubricant will be inserted through the nasogastric port for both devices. The ease of insertion will be graded from 1 to 3 (1 = easy, 2 = difficult, 3 = impossible). After successful insertion of the airway device, it will be secured with tape over the patient's check. A gel plug is applied to the orogastric port and a suprasternal notch test (gentle tapping over the suprasternal notch results in the gel to pulsate, confirming tip location behind the cricoid cartilage) will be done to confirm placement. A 14 French gauge gastric tube, pre lubricated with a water soluble lubricant will be inserted through the nasogastric port for both devices. The ease of insertion will be graded from 1 to 3 (1 = easy, 2 = difficult, 3 = impossible). Confirmation of correct orogastric tube placement will be established through aspiration of gastric contents or epigastric auscultation.
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.
Following successful SAD insertion, fibreoptic scope assessment will be conducted to evaluate LMA placement, graded based on the standardized scale by Brimacombe:
- Vocal cords not seen
- Vocal cords plus anterior epiglottis visible
- Vocal cords plus posterior epiglottis visible
- Only vocal cords visible Maintenance of general anaesthesia will be with sevoflurane with minimum alveolar concentration 1 - 2 in an oxygen-air mixture.
Postoperatively, patients will be monitored in the recovery room, with physiological variables including non-invasive blood pressure, heart rate, pulse oximetry, and respiratory rate continuously monitored. Upon full consciousness and recovery, a blinded investigator will assess for the presence of sore throat.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Ambu AuraGain | Active comparator | Device: Ambu AuraGain Supraglottic Airway DevicePatients in this group, once under general anaesthesia, will have this supraglottic airway device inserted to maintain airway patency and maintenance of general anaesthesia. |
| Air Q-3 | Active comparator | Device: Air Q-3 Supraglottic Airway DevicePatients in this group, once under general anaesthesia, will have this supraglottic airway device inserted to maintain airway patency and maintenance of general anaesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air Q-3 Supraglottic Airway DeviceOropharyngeal 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. | Device | Air Q-3 |
| Ambu AuraGain Supraglottic Airway DeviceOropharyngeal 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. | Device | Ambu AuraGain |
Primary outcome
Oropharyngeal leak pressure (OLP) of the Air-Q3 and Ambu AuraGain supraglottic airway device
Time frame: After induction of general anaesthesia until successful insertion of 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.
3 secondary outcomes
Other performance characteristics in terms of time to insertion, first pass success rate, ease of orogastric tube (OGT) insertion.
Time frame: 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
Time frame: After insertion of supraglottic airway device till performing fibreoptic scope assessment
Incidence of complications of using both SADs such as post operative sore throat
Time frame: From extubation until full consciousness in recovery area
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Results publication: PubMed 31543582Gupta 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.
- Results publication: PubMed 30189821Preece 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.
- Results publication: PubMed 30532321Singh 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.
- Results publication: PubMed 28267947Shariffuddin 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.
- Results publication: PubMed 34006053Che 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.
- Results publication: PubMed 33814586Jindal 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.
- Results publication: PubMed 8424538Brimacombe 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.
- Ambu AuraGain Official WebsiteLink provided by the sponsor.
- Air Q-3 Official WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Oropharyngeal Leak Pressure
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruiting
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
Airway Management
Not yet recruitingObservational study
Effects of Video LMA Cuff Pressure in Tympanoplasty.
Oropharyngeal Leak Pressure, Airway Management
Active, not recruiting
Comparison of Oropharyngeal Leak Pressures of SaCo Video Laryngeal Mask Airway (LMA) and ProSeal LMA in Adult Elective Surgery
Oropharengeal Leak Pressure
RecruitingObservational study
Comparison of Two Airway Devices (I-Gel and Air-Q) in Children Aged 1-10 Years During General Anesthesia
Anesthesia General, Ultrasonography
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ina Ismiarti Shariffuddin, Clinical Professor study director
Univerisity Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Q-3 Supraglottic Airway Device and Ambu AuraGain Supraglottic Airway Device in people with Oropharyngeal Leak Pressure and Supraglottic Airway, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oropharyngeal leak pressure (OLP) of the Air-Q3 and Ambu AuraGain supraglottic airway device (time frame: After induction of general anaesthesia until successful insertion of supraglottic airway device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06914453, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.