Ambu® Aura-ITM Versus Ambu Aura GainTM for Fiberoptic Intubation in Children

Overview

The investigators test the hypothesis that fiberoptic intubation (time and success rate) differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric patients

Full Title of Study: “A Randomised Non Crossover Study Comparing Ambu® Aura-ITM and Ambu® Aura GainTM for Fiberoptic Intubation in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2018

Interventions

  • Device: Ambu Aura GainTM
    • Time and success rate
  • Device: Ambu® Aura-ITM
    • Time and success rate

Arms, Groups and Cohorts

  • Active Comparator: Ambu® Aura-ITM
  • Active Comparator: Ambu Aura GainTM

Clinical Trial Outcome Measures

Primary Measures

  • Fiberoptic intubation
    • Time Frame: 5 minutes
    • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • ASA I-II – age 1.5 – 6 years – minor surgery – extraglottic airway device Exclusion Criteria:

  • age (<18 months, >6 years) – weight (<10 kg, >20 kg) – a known difficult airway – risk of aspiration

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Schulthess Klinik
  • Collaborator
    • Medical University Innsbruck
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christian Keller, MD M.Sc. – Schulthess Klinik
  • Overall Contact(s)
    • Christian Keller, MD M.Sc., 0041 44 3857462, christian.keller@kws.ch

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