---
title: Laryngeal Mask Ambu Aura Once vs. Supreme in Children
nct_id: NCT01718782
overall_status: WITHDRAWN
phase: NA
sponsor: Medical University Innsbruck
study_type: INTERVENTIONAL
primary_condition: Apnea
countries: Austria
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01718782.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01718782"
ct_last_update_post_date: 2014-05-15
last_seen_at: "2026-05-12T06:56:29.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Laryngeal Mask Ambu Aura Once vs. Supreme in Children

**Official Title:** Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children

**NCT ID:** [NCT01718782](https://clinicaltrials.gov/study/NCT01718782)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** Other studies with the same protocol have already published.
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Medical University Innsbruck
- **Conditions:** Apnea
- **Start Date:** 2013-03
- **Completion Date:** 2014-05
- **CT.gov Last Update:** 2014-05-15

## 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.

## Eligibility

- **Minimum age:** 1 Year
- **Maximum age:** 10 Years
- **Sex:** ALL
- **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
```

## Arms

- **laryngeal mask Ambu AuraOnce** (ACTIVE_COMPARATOR) — laryngeal mask Ambu AuraOnce
- **laryngeal mask LMA Supreme** (ACTIVE_COMPARATOR) — laryngeal mask LMA Supreme

## Interventions

- **laryngeal mask Ambu AuraOnce** (DEVICE) — airway management and mechanical ventilation with laryngeal mask
- **laryngeal mask LMA Supreme** (DEVICE) — airway management and mechanical ventilation with laryngeal mask

## Primary Outcomes

- **Leakage pressure [cmH2O]** _(time frame: 1min)_ — After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation

## Secondary Outcomes

- **Efficient ventilation [mL],** _(time frame: 3min)_
- **tidal volume [mL],** _(time frame: 3 minutes)_
- **stomach insufflation [yes or no]** _(time frame: 3 minutes)_

## Locations (1)

- University Hospital Innsbruck, Innsbruck, Tyrol, Austria

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospital innsbruck|innsbruck|tyrol|austria` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01718782.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01718782*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*