Airway Complication of AnaesthesiaNCT01437137
The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)
A study testing classic-laryngeal mask airway (c-LMA) and i-gel™ in people with Airway Complication of Anaesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they… Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Airway Complication of Anaesthesia
- What is being tested?
- classic-laryngeal mask airway (c-LMA) and i-gel™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Jan 2013
- 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
- infants (0-1 year of age)
- who scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Who cannot join
- patients with an abnormal airway
- with reactive airway disease
- with gastroesophageal reflux disease
- with chronic respiratory disease
- has a history of an upper respiratory tract infection in the preceding 6-week period
Trial locations and contacts
1 site in 1 country.
About this study
Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they may even be associated with more frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel 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 c-LMA in infants.
- Conditions
- Airway Complication of Anaesthesia
- Being tested
- classic-laryngeal mask airway (c-LMA), i-gel™
- Keywords
- elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic-laryngeal mask airway (c-LMA)Device
Insertion of c-LMA
i-gel™Device
Insertion of I-gel
| Study group | Role | What they receive |
|---|---|---|
| LMA group | Active comparator | Not described Receives: Device: classic-laryngeal mask airway (c-LMA) |
| I-gel group | Experimental | Not described Receives: Device: i-gel™ |
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 40 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 posted20 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnaesthesiaStudies 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
- 54 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
- NCT01437137
- Sponsor's protocol ID
- 1-2011-0052
- Status last verified
- Jun 2013
- First submitted
- 14 Sep 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Beylacq L, Bordes M, Semjen F, Cros AM. The I-gel, a single-use supraglottic airway device with a non-inflatable cuff and an esophageal vent: an observational study in children. Acta Anaesthesiol Scand. 2009 Mar;53(3):376-9. doi: 10.1111/j.1399-6576.2008.01869.x.
PubMed 19243322
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)
- ClinicalTrials.gov ID
- NCT01437137
- Acronym / sponsor ID
- 1-2011-0052
- Conditions
- Airway Complication of Anaesthesia
- Keywords
- elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Sep 2011 (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 Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they may even be associated with more frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel 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 c-LMA in infants.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA group | Active comparator | Device: classic-laryngeal mask airway (c-LMA) |
| I-gel group | Experimental | Device: i-gel™ |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- infants (0-1 year of age)
- who scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Key exclusion criteria (5 listed)
- patients with an abnormal airway
- with reactive airway disease
- with gastroesophageal reflux disease
- with chronic respiratory disease
- has 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 |
|---|---|---|
| classic-laryngeal mask airway (c-LMA)Insertion of c-LMA | Device | LMA group |
| i-gel™Insertion of I-gel | Device | I-gel 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 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
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 4 Jun 2013.
- Background: PubMed 19243322Beylacq L, Bordes M, Semjen F, Cros AM. The I-gel, a single-use supraglottic airway device with a non-inflatable cuff and an esophageal vent: an observational study in children. Acta Anaesthesiol Scand. 2009 Mar;53(3):376-9. doi: 10.1111/j.1399-6576.2008.01869.x.
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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 classic-laryngeal mask airway (c-LMA) and i-gel™ in people with Airway Complication of Anaesthesia, 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 2 inclusion and 5 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 4 Jun 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?
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 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?
On the ClinicalTrials.gov record for NCT01437137, which also lists 1 linked publication.
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 4 Jun 2013.