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

NCT03127683 | Completed DMC

• 1 other identifier: H1704-069-844
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Peak inspiratory pressure

  30 seconds after positioning of head and neck

• Tidal volume

  30 seconds after positioning of head and neck

• Fiberopic bronchoscopic view

  30 seconds after positioning of head and neck

Study Arms (1)

AuraGain group

EXPERIMENTAL

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; Other: Extension; Other: Flexion; Other: Rotation; Device: Ambu AuraGain TM

Interventions

Neutral position OTHER

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

Also known as: Neutral position of head and neck

AuraGain group

Extension OTHER

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

Also known as: Head and neck extension

AuraGain group

Flexion OTHER

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

Also known as: Head and neck flexion

AuraGain group

Rotation OTHER

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

Also known as: Head and neck rotation

AuraGain group

Ambu AuraGain TM DEVICE

Single Use Laryngeal Mask Sterile

AuraGain group

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children \< 7 years old who scheduled for general anesthesia using supraglottic airway

You may not qualify if:

• Children who require tracheal intubation
• Emergency operation without NPO
• History of C-spine surgery or disease
• History of Esophageal disease or surgery

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Rotation

Intervention Hierarchy (Ancestors)

Motion; Physical Phenomena

Study Officials

• Jin-Tae Kim, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: May 15, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: April 18, 2018

Record last verified: 2017-11

Locations

KR (1)