The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children

Study Overview
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Brief Summary
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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
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General Anesthesia

Intervention / Treatment
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* Procedure: intracuff pressure by cuff pressure manometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients (less than 108months of age) scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5 Exclusion Criteria: Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, a history of an upper respiratory tract infection

Ages Eligible for Study
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Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intra-cuff pressure 40 cmH2O<br> | Procedure: intracuff pressure by cuff pressure manometer<br>* 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.<br>|
| Active Comparator: intra-cuff pressure 60 cmH2O<br> | Procedure: intracuff pressure by cuff pressure manometer<br>* 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.<br>|
| Active Comparator: intra-cuff pressure 80 cmH2O<br> | Procedure: intracuff pressure by cuff pressure manometer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The oropharyngeal leak pressure volume |  | approximately 5 minutes after adjusting intracuff pressure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal mask airway supreme, airway sealing, intracuff pressure