Comparison of AuraGain With I-gel for Pediatric Patients
A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children
1 other identifier
interventional
68
1 country
1
Brief Summary
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.
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 Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2017
CompletedStudy Start
First participant enrolled
September 25, 2017
CompletedFirst Posted
Study publicly available on registry
September 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2018
CompletedMay 11, 2018
May 1, 2018
6 months
September 22, 2017
May 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
requirement of additional airway maneuver
including adjustment of head/neck position or insertion depth and taping of the device
during placement/maintenance of the device
Secondary Outcomes (7)
insertion time
during placement of the device
success rate
during placement of the device
ease of gastric tube insertion
within 10 minutes after device insertion
adverse effect at operating room
during anesthesia
postoperative adverse effect
within postoperative 24 hours
- +2 more secondary outcomes
Study Arms (2)
AuraGain
EXPERIMENTALAfter 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.
I-gel
ACTIVE COMPARATORAfter 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 05505, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Won Uk Koh, M.D., Ph.D.
University of Ulsan, College of Medicine, Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Instructor
Study Record Dates
First Submitted
September 22, 2017
First Posted
September 26, 2017
Study Start
September 25, 2017
Primary Completion
March 23, 2018
Study Completion
March 24, 2018
Last Updated
May 11, 2018
Record last verified: 2018-05