Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

NCT ID: NCT03118245

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

AuraGain

Intervention Type DEVICE

After anesthetic induction, AuraGain is inserted in children

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.

Group Type EXPERIMENTAL

I-gel

Intervention Type DEVICE

After anesthetic induction, I-gel is inserted in children

Interventions

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AuraGain

After anesthetic induction, AuraGain is inserted in children

Intervention Type DEVICE

I-gel

After anesthetic induction, I-gel is inserted in children

Intervention Type DEVICE

Other Intervention Names

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Ambu AuraGain I-gel supraglottic airway

Eligibility Criteria

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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
Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H1704-083-846

Identifier Type: -

Identifier Source: org_study_id

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