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

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Other: Neutral position; Other: Extension; Other: Flexion; Other: Rotation; Device: Ambu AuraGain TM

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AuraGain group; 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; The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position; Other Names: Neutral position of head and neck; Other: Extension; The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position; Other Names: Head and neck extension; Other: Flexion; The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position; Other Names: Head and neck flexion; Other: Rotation; The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position; Other Names: Head and neck rotation; Device: Ambu AuraGain TM; Single Use Laryngeal Mask Sterile

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: H1704-069-844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No