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Ambu AuraOnce Versus Ambu AuraGain LM in Children

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
University of Salzburg
Information provided by (Responsible Party):
ChristianKeller, Schulthess Klinik

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 23, 2016
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2016)		 oropharyngeal leak pressure [ Time Frame: 5 min ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2016)		 fiberoptic position [ Time Frame: 5 min ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ambu AuraOnce Versus Ambu AuraGain LM in Children
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Airway Management
Intervention  ICMJE
  • 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).
  • 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)
Study Arms  ICMJE
  • Active Comparator: Oropharyngeal leak pressure
    Ambu AuraOnce
    Intervention: Device: Ambu AuraOnce
  • Experimental: Fiberoptic position
    Ambu AuraGain
    Intervention: Device: Ambu AuraGain
Publications * Stögermüller B, Ofner S, Ziegler B, Keller C, Moser B, Gasteiger L. Ambu® Aura Gain™ versus Ambu® Aura Once™ in children: a randomized, crossover study assessing oropharyngeal leak pressure and fibreoptic position. Can J Anaesth. 2019 Jan;66(1):57-62. doi: 10.1007/s12630-018-1235-7. Epub 2018 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2016)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02811042
Other Study ID Numbers  ICMJE Schulthess_Anä_7
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ChristianKeller, Schulthess Klinik
Study Sponsor  ICMJE Schulthess Klinik
Collaborators  ICMJE University of Salzburg
Investigators  ICMJE Not Provided
PRS Account Schulthess Klinik
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP