Ambu AuraGain Laryngeal Mask Airway and I-gel in Children
A Randomized Comparison of Ambu AuraGain (Original Name of Product) Laryngeal Mask Airway and I-gel in Children
1 other identifier
interventional
94
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedSeptember 6, 2018
September 1, 2018
12 months
April 9, 2017
September 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Peak inspiratory pressure
through study completion, an average of 1 hour
Success rate
Within 5 minutes after anesthetic induction
Ease of AuraGain or I-gel insertion
Within 5 minutes after anesthetic induction
Ease of gastric tube insertion
Within 5 minutes after anesthetic induction
fiberoptic bronchoscopic veiw
Within 10 minutes after anesthetic induction
Study Arms (2)
AuraGain group
EXPERIMENTALAuraGain 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.
I-gel group
EXPERIMENTALI-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.
Interventions
Eligibility Criteria
You may qualify if:
- Children \< 7 years old who scheduled for general anesthesia using supraglottic airway
You may not qualify if:
- Children who require tracheal intubation
- Emergency operation without nil per os
- History of C-spine surgery or disease
- History of Esophageal disease or surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 9, 2017
First Posted
April 18, 2017
Study Start
June 12, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
September 6, 2018
Record last verified: 2018-09