Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Not Applicable

Withdrawn

• Conditions: Apnea
• Interventions: Device: laryngeal mask Ambu AuraOnce; Device: laryngeal mask LMA Supreme

• Registration Number: NCT01718782
• Lead Sponsor: Medical University Innsbruck

Brief Summary

The purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. The null hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The alternative hypothesis is that there is a difference in leakage pressure.

Detailed Description

Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.

Study Timeline

• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-10-31
• Study Start: 2013-03
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children aged 1-10 years
• ASA I - III
• Elective procedure in general anaesthesia
• Parental informed consent

Exclusion Criteria

• Non fasting patient
• Body mass index > 35 kg/m2
• Cervical spine pathologies or peripheral neurologic deficiences
• Malformations of upper airway or head
• Anamnestic hiatus hernia or esophageal reflux
• Status post operation of stomach or esophagus
• Recurrent respiratory infection or obstructive airway disease
• Non elective procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laryngeal mask Ambu AuraOnce	laryngeal mask Ambu AuraOnce	laryngeal mask Ambu AuraOnce
laryngeal mask LMA Supreme	laryngeal mask LMA Supreme	laryngeal mask LMA Supreme

Primary Outcome Measures

Name	Time	Method
Leakage pressure [cmH2O]	1min	After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation

Secondary Outcome Measures

Name	Time	Method
Efficient ventilation [mL],	3min	After ventilation has been established the efficient ventilation, tidal volume and stomach inflation will be measured, ie 3min after establishing ventilation
tidal volume [mL],	3 minutes
stomach insufflation [yes or no]	3 minutes

Trial Locations

Locations (1)

University Hospital Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria