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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