The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children

Study Overview
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Brief Summary
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The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated. This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway. An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg. The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.

Official Title
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The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children

Conditions
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General Anesthesia

Intervention / Treatment
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* Other: Neutral position
* Other: Extension
* Other: Flexion
* Other: Rotation
* Device: Ambu AuraGain TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children < 7 years old who scheduled for general anesthesia using supraglottic airway Exclusion Criteria: Children who require tracheal intubation Emergency operation without NPO History of C-spine surgery or disease History of Esophageal disease or surgery

Ages Eligible for Study
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Maximum Age: 7 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg. The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AuraGain group<br>An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg. The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order. | Other: Neutral position<br>* The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position<br>* Other names: Neutral position of head and neck;Other: Extension<br>* The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position<br>* Other names: Head and neck extension;Other: Flexion<br>* The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position<br>* Other names: Head and neck flexion;Other: Rotation<br>* The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position<br>* Other names: Head and neck rotation;Device: Ambu AuraGain TM<br>* Single Use Laryngeal Mask Sterile<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure | The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate was fixed at 3 L/min | 30 seconds after positioning of head and neck | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak inspiratory pressure | peak airway pressure | 30 seconds after positioning of head and neck | 
| Tidal volume | Expiratory tidal volume | 30 seconds after positioning of head and neck | 
| Fiberopic bronchoscopic view | 1. No visible glottis 2. Visible glottis and anterior epiglottis 3. Visible glottis and posterior epiglottis 4. Only visible glottis | 30 seconds after positioning of head and neck |