General AnesthesiaNCT03294226
Comparison of AuraGain With I-gel for Pediatric Patients
A study testing AuraGain and I-gel in people with General Anesthesia, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- 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
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2017to 24 Mar 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status: 1-3
- age: from 6 months to 6 year
- body weight: 5-20kg
- patients undergoing upper/lower extremity surgery at supine position
Who cannot join
- patients who do not want to participate in this study
- patients with known difficult airway including congenital facial anomaly or history of difficult airway management
- patients with aspiration risk (gastrointestinal stenosis or stricture)
- patients with symptom of upper respiratory infection on the day of surgery
- patients scheduled for day surgery
- patients judged as not eligible by researchers for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children
Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.
- 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
After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.
I-gelDevice
After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.
| Study group | Role | What they receive |
|---|---|---|
| AuraGain | Experimental | After anesthetic induction, AuraGain is inserted for airway management. Size of the device is selected according to the manufacturer's recommendation; size 1.5 for 5-10kg, size 2 for 10-20kg. Receives: Device: AuraGain |
| I-gel | Active comparator | After anesthetic induction, I-gel is inserted for airway management. Size of the device is selected according to the patient's weight; size 1.5 for 5-10kg, size 2 for 10-20kg. Receives: Device: I-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
requirement of additional airway maneuver
including adjustment of head/neck position or insertion depth and taping of the device
Measured: during placement/maintenance of the device
Secondary outcomes (7)
insertion time
Measured: during placement of the device
success rate
Measured: during placement of the device
ease of gastric tube insertion
Measured: within 10 minutes after device insertion
adverse effect at operating room
aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device
Measured: during anesthesia
postoperative adverse effect
sore throat, hoarseness, airway obstruction
Measured: within postoperative 24 hours
fiberoptic view of glottis
Brimacombe score
Measured: within 10 minutes after device insertion
oropharyngeal leak pressure
Measured: at 1 minute after device insertion, at 10 minutes after device insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start25 Sep 2017
- Primary completion23 Mar 2018
- Study completion24 Mar 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 Asan Medical CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
- Investigators
- Won Uk Koh, M.D., Ph.D., Principal investigator, University of Ulsan, College of Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294226
- Sponsor's protocol ID
- S2017-1229
- Status last verified
- May 2018
- First submitted
- 22 Sep 2017
- Last updated
- 11 May 2018
- 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 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children
- ClinicalTrials.gov ID
- NCT03294226
- Acronym / sponsor ID
- S2017-1229
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 24 Mar 2018 (actual)
- First posted
- 26 Sep 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 from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AuraGain | Experimental | Device: AuraGainAfter anesthetic induction, AuraGain is inserted for airway management. Size of the device is selected according to the manufacturer's recommendation; size 1.5 for 5-10kg, size 2 for 10-20kg. |
| I-gel | Active comparator | Device: I-gelAfter anesthetic induction, I-gel is inserted for airway management. Size of the device is selected according to the patient's weight; size 1.5 for 5-10kg, size 2 for 10-20kg. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA physical status: 1-3
- age: from 6 months to 6 year
- body weight: 5-20kg
- patients undergoing upper/lower extremity surgery at supine position
Key exclusion criteria (6 listed)
- patients who do not want to participate in this study
- patients with known difficult airway including congenital facial anomaly or history of difficult airway management
- patients with aspiration risk (gastrointestinal stenosis or stricture)
- patients with symptom of upper respiratory infection on the day of surgery
- patients scheduled for day 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 |
|---|---|---|
| AuraGainAfter anesthetic induction without neuromuscular blocking agent, AuraGain is inserted. | Device | AuraGain |
| I-gelAfter anesthetic induction without neuromuscular blocking agent, I-gel is inserted. | Device | I-gel |
Primary outcome
requirement of additional airway maneuver
Time frame: during placement/maintenance of the device
including adjustment of head/neck position or insertion depth and taping of the device
7 secondary outcomes
insertion time
Time frame: during placement of the device
success rate
Time frame: during placement of the device
ease of gastric tube insertion
Time frame: within 10 minutes after device insertion
adverse effect at operating room
Time frame: during anesthesia
postoperative adverse effect
Time frame: within postoperative 24 hours
fiberoptic view of glottis
Time frame: within 10 minutes after device insertion
oropharyngeal leak pressure
Time frame: at 1 minute after device insertion, at 10 minutes after device insertion
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 11 May 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.
Won Uk Koh, M.D., Ph.D. principal investigator
University of Ulsan, College of Medicine, Asan Medical Center
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 Asan Medical Center 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 4 inclusion and 6 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 11 May 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?
requirement of additional airway maneuver (time frame: during placement/maintenance of the device). 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 11 May 2018.