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

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Other: Neutral position; Other: Extension; Other: Flexion; Other: Rotation; Device: Ambu AuraGain TM

• Registration Number: NCT03127683
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-25
• Study Start: 2017-05-15
• Status Verified: 2017-11
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AuraGain group	Flexion	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.
AuraGain group	Ambu AuraGain TM	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.
AuraGain group	Neutral position	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.
AuraGain group	Extension	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.
AuraGain group	Rotation	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.

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	30 seconds after positioning of head and neck	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of