Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Study Overview
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Brief Summary
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The purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. The null hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The alternative hypothesis is that there is a difference in leakage pressure.

Detailed Description
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Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.

Official Title
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Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Conditions
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Apnea

Intervention / Treatment
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* Device: laryngeal mask Ambu AuraOnce
* Device: laryngeal mask LMA Supreme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 1-10 years ASA I - III Elective procedure in general anaesthesia Parental informed consent Exclusion Criteria: Non fasting patient Body mass index > 35 kg/m2 Cervical spine pathologies or peripheral neurologic deficiences Malformations of upper airway or head Anamnestic hiatus hernia or esophageal reflux Status post operation of stomach or esophagus Recurrent respiratory infection or obstructive airway disease Non elective procedure

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laryngeal mask Ambu AuraOnce<br>laryngeal mask Ambu AuraOnce | Device: laryngeal mask Ambu AuraOnce<br>* airway management and mechanical ventilation with laryngeal mask<br>|
| Active Comparator: laryngeal mask LMA Supreme<br>laryngeal mask LMA Supreme | Device: laryngeal mask LMA Supreme<br>* airway management and mechanical ventilation with laryngeal mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage pressure [cmH2O] | After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation | 1min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficient ventilation [mL], | After ventilation has been established the efficient ventilation, tidal volume and stomach inflation will be measured, ie 3min after establishing ventilation | 3min | 
| tidal volume [mL], |  | 3 minutes | 
| stomach insufflation [yes or no] |  | 3 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal mask, leakage pressure, ventilation