Skip to main content
OpenTrials
Completed

NCT Number: NCT03118245

Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started. Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be compared between two groups.

Completed

Looking for future studies?

Notify Me

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 nil per os
  • History of C-spine surgery or disease
  • History of Esophageal disease or surgery

Treatment and study plan

AuraGain

Device

After anesthetic induction, AuraGain is inserted in children

Other names: Ambu AuraGain

I-gel

Device

After anesthetic induction, I-gel is inserted in children

Other names: I-gel supraglottic airway

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 30 seconds after AuraGain or I-gel insertion

    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 is fixed at 3 liter/min

Secondary outcomes

  1. Peak inspiratory pressure

    Time frame: through study completion, an average of 1 hour

    Peak airway pressure

  2. Success rate

    Time frame: Within 5 minutes after anesthetic induction

    Success rate of AuraGain or I-gel insertion

  3. Ease of AuraGain or I-gel insertion

    Time frame: Within 5 minutes after anesthetic induction

    • No resistance 2. Moderate resistance 3. High resistance 4. Inability to pass

  4. Ease of gastric tube insertion

    Time frame: Within 5 minutes after anesthetic induction

    • Easy 2. Difficult 3. Unable to pass

  5. fiberoptic bronchoscopic veiw

    Time frame: Within 10 minutes after anesthetic induction

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Randomized Comparison of Ambu AuraGain (Original Name of Product) Laryngeal Mask Airway and I-gel in Children

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2017
Registry last updated
Sep 6, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.