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

Not Applicable

• Conditions: Anesthesia
• Interventions: Device: Ambu Aura GainTM; Device: Ambu® Aura-ITM

• Registration Number: NCT03411655
• Lead Sponsor: Schulthess Klinik

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Study First Posted: 2018-01-26
• Last Update Posted: 2018-01-26
• Study Start: 2018-03
• Primary Completion: 2018-06
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambu Aura GainTM	Ambu Aura GainTM	-
Ambu® Aura-ITM	Ambu® Aura-ITM	-

Primary Outcome Measures

Name	Time	Method
Fiberoptic intubation	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)