Laryngeal MaskNCT03544749
A Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Adult
A study testing Ambu® AuraGain™ and I-gel in people with Laryngeal Mask and Intubation; Difficult or Failed, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The supraglottic airway device(SAD), as an alternative to the endotracheal tube is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. SAD has evolved in recent years to increase efficiency and secure safety. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Laryngeal Mask, Intubation; Difficult or Failed
- What is being tested?
- Ambu® AuraGain™ and I-gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2018to 12 Oct 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate.
Who cannot join
- Body mass index > 35 kg/m2
- High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
- Criteria for difficult airway
- Patients with cervical disease or previous cervical spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Patients With Simulated Cervical Immobilization
The supraglottic airway device(SAD), as an alternative to the endotracheal tube is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. SAD has evolved in recent years to increase efficiency and secure safety. The recently developed Ambu® AuraGain™ is a second-generation SAD with a built-in gastric port and is designed to be fitted well in the larynx and oral cavity after insertion because the shaft is bent at an angle of 90 degrees and has an inflatable cuff.
In a previous study, Ambu® AuraGain™ showed a higher sealing pressure and better fibreoptic finding compared to LMA Supreme in laparoscopic surgery.
Read more
On the other hand, I-gel and Ambu® AuraGain™, both of the second-generation SAD, show comparatively excellent performance according to the results of previous studies. However, there are no studies comparing the characteristics of two airway devices in adults.
The purpose of this study is to compare the performance of I-gel and Ambu® AuraGain™ to make a difficult airway-like situation using cervical collar for adult patients receiving mechanical ventilation under general anesthesia.
- Conditions
- Laryngeal Mask, Intubation; Difficult or Failed
- Being tested
- Ambu® AuraGain™, I-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu® AuraGain™Device
After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation.
I-gelDevice
After induction of anesthesia, I-gel will be inserted for the mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Ambu® AuraGain™ group | Experimental | Not described Receives: Device: Ambu® AuraGain™ |
| I-gel group | Active comparator | Not described Receives: Device: I-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
Oropharyngeal leak pressure is measured by closing the expiratory valve and administering fresh gas flow of 6 L/min, until the equilibrium pressure is reached (to a maximum of 40 cm of H2O).
Measured: At an average of 30 seconds after insertion of laryngeal mask airway
Secondary outcomes (14)
Oropharyngeal leak pressure
Oropharyngeal leak pressure is measured by closing the expiratory valve and administering fresh gas flow of 6 L/min, until the equilibrium pressure is reached (to a maximum of 40 cm of H2O).
Measured: At 5 minute after insertion of laryngeal mask airway
The time for successful insertion of the device
The total time is measured from the removal of the face mask until bilateral chest rise with the first capnogram upstroke.
Measured: During induction of anesthesia, an average of 60 seconds
Success rate in first attempt
Successful insertion of laryngeal mask airway in a first attempt
Measured: During induction of anesthesia, an average of 60 seconds
Overall success rate
Successful insertion of laryngeal mask airway in a maximum of three attempts
Measured: During induction of anesthesia, an average of 60 seconds
The ease of insertion of device
The ease of placement was assessed using a subjective scale of 1-4 (1= no resistance, 2 = moderate resistance, 3 = high resistance, 4 = inability to place the device)
Measured: During induction of anesthesia, an average of 60 seconds
The number of attempts at insertion of device
The number of attempts for successful insertion of laryngeal mask airway
Measured: During induction of anesthesia, an average of 60 seconds
The ease of gastric tube placement
The ease of gastric tube placement was graded on a subjective scale (1 = easy, 2 = difficult, 3 = unable to pass)
Measured: During induction of anesthesia, an average of 5 minutes
The time for successful gastric tube placement
The insertion time is measured from first handling of the gastric tube to confirmation of its position in the stomach by aspiration of gastric fluid.
Measured: During induction of anesthesia, an average of 5 minutes
The grade of fiberoptic bronchoscopic view
The fiberoptic bronchoscopic view is defined as Grade 1, larynx only seen; Grade 2, larynx and epiglottis posterior surface seen; Grade 3, larynx, and epiglottis tip or anterior surface seen-visual obstruction of epiglottis to larynx: < 50%; Grade 4, epiglottis down-folded, and its anterior surface seen-visual obstruction of epiglottis to larynx: > 50%; Grade 5, epiglottis downfolded and larynx cannot be seen directly.
Measured: During induction of anesthesia, an average of 5 minutes
Peak inspiratory pressure
Peak inspiratory pressure is recorded from mechanical ventilator.
Measured: At 5 minute after insertion of laryngeal mask airway
The number of airway maneuvers required to maintain airway patency
Airway maneuvers required to maintain airway patency, including jaw thrust, head/neck extension and/or device adjustments such as advancement/withdrawal of device, and alterations to cuff volume.
Measured: During the surgery, an average of 2 hours after anesthesia induction
The type of airway maneuvers required to maintain airway patency
Airway maneuvers required to maintain airway patency, including jaw thrust, head/neck extension and/or device adjustments such as advancement/withdrawal of device, and alterations to cuff volume.
Measured: During the surgery, an average of 2 hours after anesthesia induction
Intraoperative complications
Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 < 90%), regurgitation, aspiration, blood staining of the device.
Measured: During the surgery, an average of 2 hours after anesthesia induction
Postoperative complications
Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 < 90%), nausea and vomiting.
Measured: An average of 2 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start7 Jun 2018
- Primary completion27 Sep 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal MaskStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyong Kim, Seoul National University Hospital
- Investigators
- Tae Kyong Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544749
- Sponsor's protocol ID
- 1803-124-932
- Status last verified
- Jul 2019
- First submitted
- 22 May 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Patients With Simulated Cervical Immobilization
- ClinicalTrials.gov ID
- NCT03544749
- Acronym / sponsor ID
- 1803-124-932
- Conditions
- Laryngeal Mask, Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 4 Jun 2018 (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.
The supraglottic airway device(SAD), as an alternative to the endotracheal tube is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. SAD has evolved in recent years to increase efficiency and secure safety. The recently developed Ambu® AuraGain™ is a second-generation SAD with a built-in gastric port and is designed to be fitted well in the larynx and oral cavity after insertion because the shaft is bent at an angle of 90 degrees and has an inflatable cuff.
In a previous study, Ambu® AuraGain™ showed a higher sealing pressure and better fibreoptic finding compared to LMA Supreme in laparoscopic surgery.
On the other hand, I-gel and Ambu® AuraGain™, both of the second-generation SAD, show comparatively excellent performance according to the results of previous studies. However, there are no studies comparing the characteristics of two airway devices in adults.
The purpose of this study is to compare the performance of I-gel and Ambu® AuraGain™ to make a difficult airway-like situation using cervical collar for adult patients receiving mechanical ventilation under general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ambu® AuraGain™ group | Experimental | Device: Ambu® AuraGain™ |
| I-gel group | Active comparator | Device: I-gel |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate.
Key exclusion criteria (4 listed)
- Body mass index > 35 kg/m2
- High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
- Criteria for difficult airway
- Patients with cervical disease or previous cervical spine surgery
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 |
|---|---|---|
| Ambu® AuraGain™After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation. | Device | Ambu® AuraGain™ group |
| I-gelAfter induction of anesthesia, I-gel will be inserted for the mechanical ventilation. | Device | I-gel group |
Primary outcome
Oropharyngeal leak pressure
Time frame: At an average of 30 seconds after insertion of laryngeal mask airway
Oropharyngeal leak pressure is measured by closing the expiratory valve and administering fresh gas flow of 6 L/min, until the equilibrium pressure is reached (to a maximum of 40 cm of H2O).
14 secondary outcomes
Oropharyngeal leak pressure
Time frame: At 5 minute after insertion of laryngeal mask airway
The time for successful insertion of the device
Time frame: During induction of anesthesia, an average of 60 seconds
Success rate in first attempt
Time frame: During induction of anesthesia, an average of 60 seconds
Overall success rate
Time frame: During induction of anesthesia, an average of 60 seconds
The ease of insertion of device
Time frame: During induction of anesthesia, an average of 60 seconds
The number of attempts at insertion of device
Time frame: During induction of anesthesia, an average of 60 seconds
The ease of gastric tube placement
Time frame: During induction of anesthesia, an average of 5 minutes
The time for successful gastric tube placement
Time frame: During induction of anesthesia, an average of 5 minutes
The grade of fiberoptic bronchoscopic view
Time frame: During induction of anesthesia, an average of 5 minutes
Peak inspiratory pressure
Time frame: At 5 minute after insertion of laryngeal mask airway
The number of airway maneuvers required to maintain airway patency
Time frame: During the surgery, an average of 2 hours after anesthesia induction
The type of airway maneuvers required to maintain airway patency
Time frame: During the surgery, an average of 2 hours after anesthesia induction
Intraoperative complications
Time frame: During the surgery, an average of 2 hours after anesthesia induction
Postoperative complications
Time frame: An average of 2 hours after extubation
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 18 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Laryngeal Mask
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Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
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Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
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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.
Tae Kyong Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu® AuraGain™ and I-gel in people with Laryngeal Mask and Intubation; Difficult or Failed, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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 18 Jul 2019. 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 South Korea. 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 (time frame: At an average of 30 seconds after insertion of laryngeal mask airway). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.