Comparison of AuraGain With I-gel for Pediatric Patients

May 10, 2018 updated by: Hajung Kim, Asan Medical Center

A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children

Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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

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

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status: 1-3
  • age: from 6 months to 6 year
  • body weight: 5-20kg
  • patients undergoing upper/lower extremity surgery at supine position

Exclusion Criteria:

  • patients who do not want to participate in this study
  • patients with known difficult airway including congenital facial anomaly or history of difficult airway management
  • patients with aspiration risk (gastrointestinal stenosis or stricture)
  • patients with symptom of upper respiratory infection on the day of surgery
  • patients scheduled for day surgery
  • patients judged as not eligible by researchers for other reasons

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AuraGain
After anesthetic induction, AuraGain is inserted for airway management. Size of the device is selected according to the manufacturer's recommendation; size 1.5 for 5-10kg, size 2 for 10-20kg.
Device: AuraGain
After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.
Active Comparator: I-gel
After anesthetic induction, I-gel is inserted for airway management. Size of the device is selected according to the patient's weight; size 1.5 for 5-10kg, size 2 for 10-20kg.
Device: I-gel
After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
requirement of additional airway maneuver
Time Frame: during placement/maintenance of the device
including adjustment of head/neck position or insertion depth and taping of the device
during placement/maintenance of the device

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: during placement of the device
during placement of the device
success rate
Time Frame: during placement of the device
during placement of the device
ease of gastric tube insertion
Time Frame: within 10 minutes after device insertion
within 10 minutes after device insertion
adverse effect at operating room
Time Frame: during anesthesia
aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device
during anesthesia
postoperative adverse effect
Time Frame: within postoperative 24 hours
sore throat, hoarseness, airway obstruction
within postoperative 24 hours
fiberoptic view of glottis
Time Frame: within 10 minutes after device insertion
Brimacombe score
within 10 minutes after device insertion
oropharyngeal leak pressure
Time Frame: at 1 minute after device insertion, at 10 minutes after device insertion
at 1 minute after device insertion, at 10 minutes after device insertion

Collaborators and Investigators

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

Sponsor

Asan Medical Center

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)

September 25, 2017

Primary Completion (Actual)

March 23, 2018

Study Completion (Actual)

March 24, 2018

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • S2017-1229

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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