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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorenz Theiler, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01692522
First received: September 17, 2012
Last updated: August 14, 2014
Last verified: August 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • First attempt visualized blind intubation success rate [ Time Frame: how many seconds needed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall intubation success rate [ Time Frame: how many seconds needed ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Lorenz Theiler, Principal Investigator, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01692522     History of Changes
Other Study ID Numbers: 093/12
Study First Received: September 17, 2012
Last Updated: August 14, 2014
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on August 28, 2014