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NCT01692522 Clinical Trial

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

Intubation; Difficult Clinical Trial

Official title:
Comparison of the Pediatric Intubation on Laryngeal Masks Ambu Aira-i and AirQ for Simulated Blind Intubation in Anesthetized Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01692522
Other study ID # 093/12
Secondary ID
Status Completed
Phase N/A
First received September 17, 2012
Last updated August 14, 2014
Start date October 2012
Est. completion date August 2014

Study information
Verified date August 2014
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 16 Years
Eligibility Inclusion Criteria:

- 0-16 years

- max 50kg

- ASA I-III

Exclusion Criteria:

- risk of aspiration

- known difficult airway

- congenital malformations respiratory tract

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Procedure:
• Intubation
visualized blind intubation

Locations
Country Name City State
Switzerland Bern University Hospital Bern

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary First attempt visualized blind intubation success rate how many seconds needed No
Secondary Overall intubation success rate how many seconds needed No
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