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Ambu AuraOnce Versus Ambu AuraGain LM 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: NCT02811042
Recruitment Status : Unknown
Verified June 2016 by ChristianKeller, Schulthess Klinik.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
University of Salzburg
Information provided by (Responsible Party):
ChristianKeller, Schulthess Klinik

Brief Summary:
The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.

Condition or disease Intervention/treatment Phase
Airway Management Device: Ambu AuraOnce Device: Ambu AuraGain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Laryngeal Mask Ambu AuraOnce Versus Laryngeal Mask Ambu AuraGain in Non-paralysed, Anesthetized Children: A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position
Study Start Date : July 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Active Comparator: Oropharyngeal leak pressure
Ambu AuraOnce
Device: Ambu AuraOnce
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

Experimental: Fiberoptic position
Ambu AuraGain
Device: Ambu AuraGain
The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)

Primary Outcome Measures :
  1. oropharyngeal leak pressure [ Time Frame: 5 min ]

Secondary Outcome Measures :
  1. fiberoptic position [ Time Frame: 5 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA I-II
  • age 1 - 16 years
  • minor surgery
  • extraglottic airway device

Exclusion Criteria:

  • age (<12 months, >16 years)
  • weight (<12 kg, >50 kg)
  • a known difficult airway
  • risk of aspiration

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): NCT02811042

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Zentralkrankenhaus Bozen
Bozen, Italy, 39100
Christian Keller MD, M.Sc.
Zürich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
University of Salzburg
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ChristianKeller, PD Dr. med. M.Sc., Schulthess Klinik Identifier: NCT02811042    
Other Study ID Numbers: Schulthess_Anä_7
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No