Laryngeal Mask Ambu Aura Once vs. Supreme in Children

May 14, 2014 updated by: Peter Paal, Medical University Innsbruck

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • University Hospital Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laryngeal mask Ambu AuraOnce
Device: laryngeal mask Ambu AuraOnce
airway management and mechanical ventilation with laryngeal mask
Active Comparator: laryngeal mask LMA Supreme
Device: laryngeal mask LMA Supreme
airway management and mechanical ventilation with laryngeal mask

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Peter Paal, MD,DESA,EDIC, University Hospital Innsbruck, Department of Anaesthesia + Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (Estimate)

October 31, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AN4111 292/4.23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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