Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

September 4, 2018 updated by: Jin-Tae Kim, Seoul National University Hospital

A Randomized Comparison of Ambu AuraGain (Original Name of Product) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AuraGain group
AuraGain is inserted for maintenance of general anesthesia. The size 1 is for children <5kg, size 2 for 5-10kg, size 2 for 10-20kg, and size 2.5 for 20-30kg.
Device: AuraGain
After anesthetic induction, AuraGain is inserted in children
Other Names:
  • Ambu AuraGain
Experimental: I-gel group
I-gel is s inserted for maintenance of general anesthesia. The size 1 is for children weighted 2-5kg, size 2 for 5-12kg, size 2 for 10-25kg, and size 2.5 for 25-35kg.
Device: I-gel
After anesthetic induction, I-gel is inserted in children
Other Names:
  • I-gel supraglottic airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 seconds after AuraGain or I-gel insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak inspiratory pressure
Time Frame: through study completion, an average of 1 hour
Peak airway pressure
through study completion, an average of 1 hour
Success rate
Time Frame: Within 5 minutes after anesthetic induction
Success rate of AuraGain or I-gel insertion
Within 5 minutes after anesthetic induction
Ease of AuraGain or I-gel insertion
Time Frame: Within 5 minutes after anesthetic induction
1. No resistance 2. Moderate resistance 3. High resistance 4. Inability to pass
Within 5 minutes after anesthetic induction
Ease of gastric tube insertion
Time Frame: Within 5 minutes after anesthetic induction
1. Easy 2. Difficult 3. Unable to pass
Within 5 minutes after anesthetic induction
fiberoptic bronchoscopic veiw
Time Frame: Within 10 minutes after anesthetic induction
1. No visible glottis 2. Visible glottis and anterior epiglottis 3. Visible glottis and posterior epiglottis 4. Only glottis is visible
Within 10 minutes after anesthetic induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

April 9, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • H1704-083-846

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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