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Completed

NCT Number: NCT03127683

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.

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Key information

Conditions

General Anesthesia

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neutral position

Other

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

Extension

Other

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

Flexion

Other

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

Rotation

Other

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

Ambu AuraGain TM

Device

Single Use Laryngeal Mask Sterile

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 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 outcomes

  1. Peak inspiratory pressure

    Time frame: 30 seconds after positioning of head and neck

    peak airway pressure

  2. Tidal volume

    Time frame: 30 seconds after positioning of head and neck

    Expiratory tidal volume

  3. Fiberopic bronchoscopic view

    Time frame: 30 seconds after positioning of head and neck

    • No visible glottis 2. Visible glottis and anterior epiglottis 3. Visible glottis and posterior epiglottis 4. Only visible glottis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2017
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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