The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children
1 other identifier
interventional
36
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 22, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedApril 8, 2014
April 1, 2014
6 months
November 22, 2012
April 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The oropharyngeal leak pressure volume
approximately 5 minutes after adjusting intracuff pressure
Study Arms (3)
intra-cuff pressure 40 cmH2O
EXPERIMENTALintra-cuff pressure 60 cmH2O
ACTIVE COMPARATORintra-cuff pressure 80 cmH2O
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Pediatric patients (less than 108months of age)
- scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5
You may not qualify if:
- Patients with an abnormal airway,
- reactive airway disease,
- gastroesophageal reflux disease,
- chronic respiratory disease,
- a history of an upper respiratory tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance hospital
Seoul, Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 21533663BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2012
First Posted
November 30, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
April 8, 2014
Record last verified: 2014-04