Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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laryngeal mask Ambu AuraOnce

Group Type ACTIVE_COMPARATOR

laryngeal mask Ambu AuraOnce

Intervention Type DEVICE

airway management and mechanical ventilation with laryngeal mask

laryngeal mask LMA Supreme

Group Type ACTIVE_COMPARATOR

laryngeal mask LMA Supreme

Intervention Type DEVICE

airway management and mechanical ventilation with laryngeal mask

Interventions

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laryngeal mask Ambu AuraOnce

airway management and mechanical ventilation with laryngeal mask

Intervention Type DEVICE

laryngeal mask LMA Supreme

airway management and mechanical ventilation with laryngeal mask

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes