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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127683
• Other study ID #: H1704-069-844
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: April 16, 2018
• Start date: May 15, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: November 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Other:
• Neutral position
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
• Extension
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
• Flexion
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
• Rotation
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

Device:
• Ambu AuraGain TM
Single Use Laryngeal Mask Sterile

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Peak inspiratory pressure	peak airway pressure	30 seconds after positioning of head and neck
Secondary	Tidal volume	Expiratory tidal volume	30 seconds after positioning of head and neck
Secondary	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