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NCT03118245 Clinical Trial

Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03118245
Other study ID # H1704-083-846
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2017
Est. completion date May 31, 2018

Study information
Verified date September 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 94
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 7 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• AuraGain
After anesthetic induction, AuraGain is inserted in children
• I-gel
After anesthetic induction, I-gel is inserted in children

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oropharyngeal leak pressure 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 Peak inspiratory pressure Peak airway pressure through study completion, an average of 1 hour
Secondary Success rate Success rate of AuraGain or I-gel insertion Within 5 minutes after anesthetic induction
Secondary Ease of AuraGain or I-gel insertion 1. No resistance 2. Moderate resistance 3. High resistance 4. Inability to pass Within 5 minutes after anesthetic induction
Secondary Ease of gastric tube insertion 1. Easy 2. Difficult 3. Unable to pass Within 5 minutes after anesthetic induction
Secondary fiberoptic bronchoscopic veiw 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
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