Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01718782

Enrollment

Registered

2012-10-31

Start date

2013-03-31

Completion date

2014-05-31

Last updated

2014-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea

Keywords

laryngeal mask, leakage pressure, ventilation

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.

Interventions

DEVICElaryngeal mask Ambu AuraOnce

airway management and mechanical ventilation with laryngeal mask

DEVICElaryngeal mask LMA Supreme

airway management and mechanical ventilation with laryngeal mask

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Years to 10 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026