Ambu AuraOnce Versus Ambu AuraGain LM in Children

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02811042
• Other study ID #: Schulthess_Anä_7
• Status: Not yet recruiting
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 20, 2016
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: June 2016
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Management

Intervention

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).
• 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)

Locations

Country	Name	City	State
Italy	Zentralkrankenhaus Bozen	Bozen
Switzerland	Christian Keller MD, M.Sc.	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Schulthess Klinik	University of Salzburg

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oropharyngeal leak pressure		5 min	Yes
Secondary	fiberoptic position		5 min	Yes