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Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

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: NCT03118245
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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.

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 : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Comparison of Ambu AuraGain (Original Name of Product) Laryngeal Mask Airway and I-gel in Children
Actual Study Start Date : June 12, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Arm Intervention/treatment
Experimental: 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.
Device: AuraGain
After anesthetic induction, AuraGain is inserted in children
Other Name: Ambu AuraGain

Experimental: 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.
Device: I-gel
After anesthetic induction, I-gel is inserted in children
Other Name: I-gel supraglottic airway




Primary Outcome Measures :
  1. Oropharyngeal leak pressure [ Time Frame: 30 seconds after AuraGain or I-gel insertion ]
    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


Secondary Outcome Measures :
  1. Peak inspiratory pressure [ Time Frame: through study completion, an average of 1 hour ]
    Peak airway pressure

  2. Success rate [ Time Frame: Within 5 minutes after anesthetic induction ]
    Success rate of AuraGain or I-gel insertion

  3. Ease of AuraGain or I-gel insertion [ Time Frame: Within 5 minutes after anesthetic induction ]
    1. No resistance 2. Moderate resistance 3. High resistance 4. Inability to pass

  4. Ease of gastric tube insertion [ Time Frame: Within 5 minutes after anesthetic induction ]
    1. Easy 2. Difficult 3. Unable to pass

  5. fiberoptic bronchoscopic veiw [ Time Frame: Within 10 minutes after anesthetic induction ]
    1. No visible glottis 2. Visible glottis and anterior epiglottis 3. Visible glottis and posterior epiglottis 4. Only glottis is visible



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03118245


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, PhD Seoul National University Hospital
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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03118245    
Other Study ID Numbers: H1704-083-846
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 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