Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic AirwayNCT01863316
The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants
A study testing I gel and LMA Supreme in people with Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway, run by Yonsei University at 1 site in South Korea.
Trial summary
Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway
- What is being tested?
- I gel and LMA Supreme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to May 2015
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Who cannot join
- 1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
Seoul, Seoul, 120-752
Jeong-Rim LEE, MD, 02-2227-3840, MANYA@yuhs.ac
About this study
Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.
- Being tested
- I gel, LMA Supreme
- Keywords
- LMA Supreme, i-gel, supraglottic airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I gelDevice
LMA SupremeDevice
| Study group | Role | What they receive |
|---|---|---|
| 1) I gel group | Experimental | using supraglottic airway I gel Receives: Device: I gel |
| 2) LMA Supreme group | Active comparator | using supraglottic airway LMA Supreme Receives: Device: LMA Supreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway leak pressure
Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 30 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
Measured: within 5 min of 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 posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic AirwayStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863316
- Sponsor's protocol ID
- 1-2013-0023
- Status last verified
- May 2013
- First submitted
- 22 May 2013
- Last updated
- 27 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants
- ClinicalTrials.gov ID
- NCT01863316
- Acronym / sponsor ID
- 1-2013-0023
- Keywords
- LMA Supreme, i-gel, supraglottic airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 27 May 2013 (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.
Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) I gel group | Experimental | Device: I gelusing supraglottic airway I gel |
| 2) LMA Supreme group | Active comparator | Device: LMA Supremeusing supraglottic airway LMA Supreme |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Key exclusion criteria (1 listed)
- 1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
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 |
|---|---|---|
| I gel | Device | 1) I gel group |
| LMA Supreme | Device | 2) LMA Supreme group |
Primary outcome
airway leak pressure
Time frame: within 5 min of insertion of each device
Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 30 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I gel and LMA Supreme in people with Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway, 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: status not confirmed, as of the sponsor's last update on 27 May 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-Rim LEE, MD (02-2227-3840, MANYA@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airway leak pressure (time frame: within 5 min of 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 27 May 2013.