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Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ 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. Identifier: NCT01692522
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : August 18, 2014
Information provided by (Responsible Party):
Lorenz Theiler, University Hospital Inselspital, Berne

Brief Summary:
The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.

Condition or disease Intervention/treatment Phase
Intubation; Difficult Procedure: Intubation Not Applicable

Detailed Description:
After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope, but the scope visualizes the course of the tracheal tube in the laryngeal mask and the glottic opening as if the tracheal tube was advanced blindly: Visualized blind intubation

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Comparison of the Pediatric Intubation on Laryngeal Masks Ambu Aira-i and AirQ for Simulated Blind Intubation in Anesthetized Children
Study Start Date : October 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Ambu Aura-i
Procedure: Intubation
visualized blind intubation

Active Comparator: AirQ
Procedure: Intubation
visualized blind intubation

Primary Outcome Measures :
  1. First attempt visualized blind intubation success rate [ Time Frame: how many seconds needed ]

Secondary Outcome Measures :
  1. Overall intubation success rate [ Time Frame: how many seconds needed ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 0-16 years
  • max 50kg

Exclusion Criteria:

  • risk of aspiration
  • known difficult airway
  • congenital malformations respiratory tract

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 identifier (NCT number): NCT01692522

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Bern University Hospital
Bern, Switzerland
Sponsors and Collaborators
University Hospital Inselspital, Berne
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Study Chair: Robert Greif, MD MME FERC University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lorenz Theiler, Principal Investigator, University Hospital Inselspital, Berne Identifier: NCT01692522    
Other Study ID Numbers: 093/12
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014