General AnesthesiaNCT01738854
The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children
A study testing intracuff pressure by cuff pressure manometer in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. Read more about this study
- Who is it for?
- Ages Up to 9 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- intracuff pressure by cuff pressure manometer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Jul 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients (less than 108months of age)
- scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5
Who cannot join
- Patients with an abnormal airway,
- reactive airway disease,
- gastroesophageal reflux disease,
- chronic respiratory disease,
- a history of an upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
About this study
The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at various intracuff pressure in children.
- Conditions
- General Anesthesia
- Being tested
- intracuff pressure by cuff pressure manometer
- Keywords
- laryngeal mask airway supreme, airway sealing, intracuff pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracuff pressure by cuff pressure manometerProcedure or surgery
36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.
| Study group | Role | What they receive |
|---|---|---|
| intra-cuff pressure 40 cmH2O | Experimental | Not described Receives: Procedure: intracuff pressure by cuff pressure manometer |
| intra-cuff pressure 60 cmH2O | Active comparator | Not described Receives: Procedure: intracuff pressure by cuff pressure manometer |
| intra-cuff pressure 80 cmH2O | Active comparator | Not described Receives: Procedure: intracuff pressure by cuff pressure manometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The oropharyngeal leak pressure volume
Measured: approximately 5 minutes after adjusting intracuff pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionJul 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 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
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 36 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
- NCT01738854
- Sponsor's protocol ID
- 1-2012-0043
- Status last verified
- Apr 2014
- First submitted
- 22 Nov 2012
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang L, Seet E, Mehta V, Subramanyam R, Ankichetty SP, Wong DT, Chung F. Oropharyngeal leak pressure with the laryngeal mask airway Supreme at different intracuff pressures: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):624-629. doi: 10.1007/s12630-011-9514-6. Epub 2011 Apr 30.
PubMed 21533663
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children
- ClinicalTrials.gov ID
- NCT01738854
- Acronym / sponsor ID
- 1-2012-0043
- Conditions
- General Anesthesia
- Keywords
- laryngeal mask airway supreme, airway sealing, intracuff pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Nov 2012 (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.
The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at various intracuff pressure in children.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intra-cuff pressure 40 cmH2O | Experimental | Procedure: intracuff pressure by cuff pressure manometer |
| intra-cuff pressure 60 cmH2O | Active comparator | Procedure: intracuff pressure by cuff pressure manometer |
| intra-cuff pressure 80 cmH2O | Active comparator | Procedure: intracuff pressure by cuff pressure manometer |
Who may qualify
- Ages
- Up to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients (less than 108months of age)
- scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5
Key exclusion criteria (5 listed)
- Patients with an abnormal airway,
- reactive airway disease,
- gastroesophageal reflux disease,
- chronic respiratory disease,
- a history of an 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 |
|---|---|---|
| intracuff pressure by cuff pressure manometer36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure. | Procedure or surgery | intra-cuff pressure 40 cmH2O, intra-cuff pressure 60 cmH2O, intra-cuff pressure 80 cmH2O |
Primary outcome
The oropharyngeal leak pressure volume
Time frame: approximately 5 minutes after adjusting intracuff pressure
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 8 Apr 2014.
- Background: PubMed 21533663Zhang L, Seet E, Mehta V, Subramanyam R, Ankichetty SP, Wong DT, Chung F. Oropharyngeal leak pressure with the laryngeal mask airway Supreme at different intracuff pressures: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):624-629. doi: 10.1007/s12630-011-9514-6. Epub 2011 Apr 30.
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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 intracuff pressure by cuff pressure manometer in people with General Anesthesia, 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 8 Apr 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?
The oropharyngeal leak pressure volume (time frame: approximately 5 minutes after adjusting intracuff pressure). 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 NCT01738854, 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 8 Apr 2014.