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Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01692522
First Posted: September 25, 2012
Last Update Posted: August 18, 2014
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.
Information provided by (Responsible Party):
Lorenz Theiler, University Hospital Inselspital, Berne
  Purpose
The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.

Condition Intervention
Intubation; Difficult Procedure: Intubation

Study Type: Interventional
Study Design: 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

Further study details as provided by Lorenz Theiler, University Hospital Inselspital, Berne:

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

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

Estimated Enrollment: 80
Study Start Date: October 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ambu Aura-i
intubation
Procedure: Intubation
visualized blind intubation
Active Comparator: AirQ
intubation
Procedure: Intubation
visualized blind intubation

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
  Eligibility

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
Criteria

Inclusion Criteria:

  • 0-16 years
  • max 50kg
  • ASA I-III

Exclusion Criteria:

  • risk of aspiration
  • known difficult airway
  • congenital malformations respiratory tract
  Contacts and Locations
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): NCT01692522


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lorenz Theiler, Principal Investigator, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01692522     History of Changes
Other Study ID Numbers: 093/12
First Submitted: September 17, 2012
First Posted: September 25, 2012
Last Update Posted: August 18, 2014
Last Verified: August 2014