Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Medical University Innsbruck

Status: Withdrawn

Conditions: Apnea

Treatments: Device: laryngeal mask LMA Supreme; Device: laryngeal mask Ambu AuraOnce

Study type: Interventional

Funder types: Other

Identifiers

NCT01718782

AN4111 292/4.23

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

laryngeal mask Ambu AuraOnce

Active Comparator group

Description:

laryngeal mask Ambu AuraOnce

Treatment:

Device: laryngeal mask Ambu AuraOnce

laryngeal mask LMA Supreme

Active Comparator group

Description:

laryngeal mask LMA Supreme

Treatment:

Device: laryngeal mask LMA Supreme