NCT02811042

Ambu AuraOnce Versus Ambu AuraGain LM in Children

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Schulthess Klinik · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Airway Management

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-02-01
• Completion: 2017-03-01
• First posted: 2016-06-23
• Last updated: 2016-06-23

Locations

2 sites across 2 countries: Italy, Switzerland