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Comparison of AuraGain With I-gel for Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294226
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hajung Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
General Anesthesia Device: AuraGain Device: I-gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : March 23, 2018
Actual Study Completion Date : March 24, 2018

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. insertion time [ Time Frame: during placement of the device ]
  2. success rate [ Time Frame: during placement of the device ]
  3. ease of gastric tube insertion [ Time Frame: within 10 minutes after device insertion ]
  4. 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

  5. postoperative adverse effect [ Time Frame: within postoperative 24 hours ]
    sore throat, hoarseness, airway obstruction

  6. fiberoptic view of glottis [ Time Frame: within 10 minutes after device insertion ]
    Brimacombe score

  7. oropharyngeal leak pressure [ Time Frame: at 1 minute after device insertion, at 10 minutes after device insertion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294226


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Won Uk Koh, M.D., Ph.D. University of Ulsan, College of Medicine, Asan Medical Center
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Responsible Party: Hajung Kim, Clinical Instructor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03294226    
Other Study ID Numbers: S2017-1229
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No