Ambu AuraOnce Versus Ambu AuraGain LM in Children

Not Applicable

• Conditions: Airway Management
• Interventions: Device: Ambu AuraOnce; Device: Ambu AuraGain

• Registration Number: NCT02811042
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-20
• Last Update Submitted: 2016-06-20
• Study First Posted: 2016-06-23
• Last Update Posted: 2016-06-23
• Study Start: 2016-07
• Primary Completion: 2017-02
• Study Completion: 2017-03

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oropharyngeal leak pressure	Ambu AuraOnce	Ambu AuraOnce
Fiberoptic position	Ambu AuraGain	Ambu AuraGain

Primary Outcome Measures

Name	Time	Method
oropharyngeal leak pressure	5 min

Secondary Outcome Measures

Name	Time	Method
fiberoptic position	5 min

Trial Locations

Locations (2)

Christian Keller MD, M.Sc.; 🇨🇭 Zürich, Switzerland

Zentralkrankenhaus Bozen; 🇮🇹 Bozen, Italy