General AnesthesiaNCT02140008
A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children
A study testing Insertion of I-gel and Insertion of air-Q in people with General Anesthesia and Supraglottic Airway Devices, run by Yonsei University at 1 site in South Korea.
Trial summary
Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. Read more about this study
- Who is it for?
- Ages 1 month to 108 months
- Conditions the study is for
- General Anesthesia, Supraglottic Airway Devices
- What is being tested?
- Insertion of I-gel and Insertion of air-Q
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Aug 2014
- 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 1 month to 108 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Who cannot join
- Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.
- Conditions
- General Anesthesia, Supraglottic Airway Devices
- Being tested
- Insertion of I-gel, Insertion of air-Q
- Keywords
- supraglottic airway devices, the i-gel, the self-pressurised air-Q intubating laryngeal airway,, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of I-gelDevice
After induction of general anesthesia, I-gel will be inserted according to randomly allocated group.
Insertion of air-QDevice
After induction of general anesthesia, air-Q was inserted according to randomly allocated group.
| Study group | Role | What they receive |
|---|---|---|
| I-gel group | Experimental | Not described Receives: Device: Insertion of I-gel |
| Air-Q group | Active comparator | Not described Receives: Device: Insertion of air-Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway leak pressure
Measured: within 5 min after insertion of each device
Secondary outcomes (1)
Insertion time (insertion parameter)
insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography.
Measured: During and 1 min after insertion of each device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionAug 2014
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 Yonsei UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140008
- Sponsor's protocol ID
- 1-2014-0011
- Status last verified
- Sep 2014
- First submitted
- 12 May 2014
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children
- ClinicalTrials.gov ID
- NCT02140008
- Acronym / sponsor ID
- 1-2014-0011
- Conditions
- General Anesthesia, Supraglottic Airway Devices
- Keywords
- supraglottic airway devices, the i-gel, the self-pressurised air-Q intubating laryngeal airway,, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 May 2014 (estimated)
- 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.
Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-gel group | Experimental | Device: Insertion of I-gel |
| Air-Q group | Active comparator | Device: Insertion of air-Q |
Who may qualify
- Ages
- 1 month to 108 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Key exclusion criteria (1 listed)
- Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection
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 |
|---|---|---|
| Insertion of I-gelAfter induction of general anesthesia, I-gel will be inserted according to randomly allocated group. | Device | I-gel group |
| Insertion of air-QAfter induction of general anesthesia, air-Q was inserted according to randomly allocated group. | Device | Air-Q group |
Primary outcome
airway leak pressure
Time frame: within 5 min after insertion of each device
1 secondary outcome
Insertion time (insertion parameter)
Time frame: During and 1 min after insertion of each device
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 23 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of I-gel and Insertion of air-Q in people with General Anesthesia and Supraglottic Airway Devices, run by Yonsei University 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 1 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 23 Sep 2014. 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?
airway leak pressure (time frame: within 5 min after insertion of each 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 23 Sep 2014.