General AnesthesiaNCT03118245
Ambu AuraGain Laryngeal Mask Airway and I-gel in Children
A study testing AuraGain and I-gel in people with General Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- AuraGain and I-gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2017to 31 May 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 Up to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children < 7 years old who scheduled for general anesthesia using supraglottic airway
Who cannot join
- Children who require tracheal intubation
- Emergency operation without nil per os
- History of C-spine surgery or disease
- History of Esophageal disease or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Ambu AuraGain (Original Name of Product) Laryngeal Mask Airway and I-gel in Children
Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started. Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be compared between two groups.
- Conditions
- General Anesthesia
- Being tested
- AuraGain, I-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuraGainDevice
Also called Ambu AuraGain
After anesthetic induction, AuraGain is inserted in children
I-gelDevice
Also called I-gel supraglottic airway
After anesthetic induction, I-gel is inserted in children
| Study group | Role | What they receive |
|---|---|---|
| AuraGain group | Experimental | AuraGain is inserted for maintenance of general anesthesia. The size 1 is for children <5kg, size 2 for 5-10kg, size 2 for 10-20kg, and size 2.5 for 20-30kg. Receives: Device: AuraGain |
| I-gel group | Experimental | I-gel is s inserted for maintenance of general anesthesia. The size 1 is for children weighted 2-5kg, size 2 for 5-12kg, size 2 for 10-25kg, and size 2.5 for 25-35kg. Receives: Device: I-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate is fixed at 3 liter/min
Measured: 30 seconds after AuraGain or I-gel insertion
Secondary outcomes (5)
Peak inspiratory pressure
Peak airway pressure
Measured: through study completion, an average of 1 hour
Success rate
Success rate of AuraGain or I-gel insertion
Measured: Within 5 minutes after anesthetic induction
Ease of AuraGain or I-gel insertion
- No resistance 2. Moderate resistance 3. High resistance 4. Inability to pass
Measured: Within 5 minutes after anesthetic induction
Ease of gastric tube insertion
- Easy 2. Difficult 3. Unable to pass
Measured: Within 5 minutes after anesthetic induction
fiberoptic bronchoscopic veiw
- No visible glottis 2. Visible glottis and anterior epiglottis 3. Visible glottis and posterior epiglottis 4. Only glottis is visible
Measured: Within 10 minutes after anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start12 Jun 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118245
- Sponsor's protocol ID
- H1704-083-846
- Status last verified
- Sep 2018
- First submitted
- 9 Apr 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Ambu AuraGain (Original Name of Product) Laryngeal Mask Airway and I-gel in Children
- ClinicalTrials.gov ID
- NCT03118245
- Acronym / sponsor ID
- H1704-083-846
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 18 Apr 2017 (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.
Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started. Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be compared between two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AuraGain group | Experimental | Device: AuraGainAuraGain is inserted for maintenance of general anesthesia. The size 1 is for children <5kg, size 2 for 5-10kg, size 2 for 10-20kg, and size 2.5 for 20-30kg. |
| I-gel group | Experimental | Device: I-gelI-gel is s inserted for maintenance of general anesthesia. The size 1 is for children weighted 2-5kg, size 2 for 5-12kg, size 2 for 10-25kg, and size 2.5 for 25-35kg. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children < 7 years old who scheduled for general anesthesia using supraglottic airway
Key exclusion criteria (4 listed)
- Children who require tracheal intubation
- Emergency operation without nil per os
- History of C-spine surgery or disease
- History of Esophageal disease or 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 |
|---|---|---|
| AuraGainAlso: Ambu AuraGainAfter anesthetic induction, AuraGain is inserted in children | Device | AuraGain group |
| I-gelAlso: I-gel supraglottic airwayAfter anesthetic induction, I-gel is inserted in children | Device | I-gel group |
Primary outcome
Oropharyngeal leak pressure
Time frame: 30 seconds after AuraGain or I-gel insertion
The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate is fixed at 3 liter/min
5 secondary outcomes
Peak inspiratory pressure
Time frame: through study completion, an average of 1 hour
Success rate
Time frame: Within 5 minutes after anesthetic induction
Ease of AuraGain or I-gel insertion
Time frame: Within 5 minutes after anesthetic induction
Ease of gastric tube insertion
Time frame: Within 5 minutes after anesthetic induction
fiberoptic bronchoscopic veiw
Time frame: Within 10 minutes after anesthetic induction
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 6 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jin-Tae Kim, 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 AuraGain and I-gel in people with General Anesthesia, 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 6 Sep 2018. 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: 30 seconds after AuraGain or I-gel insertion). 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 6 Sep 2018.