Ambu AuraOnce Versus Ambu AuraGain LM in Children

June 20, 2016 updated by: ChristianKeller, Schulthess Klinik

Laryngeal Mask Ambu AuraOnce Versus Laryngeal Mask Ambu AuraGain in Non-paralysed, Anesthetized Children: A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position

The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Italy
      • Bozen, Italy, 39100
        • Zentralkrankenhaus Bozen
  • Switzerland
      • Zürich, Switzerland, 8008
        • Christian Keller MD, M.Sc.

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 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II
  • age 1 - 16 years
  • minor surgery
  • extraglottic airway device

Exclusion Criteria:

  • age (<12 months, >16 years)
  • weight (<12 kg, >50 kg)
  • a known difficult airway
  • risk of aspiration

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oropharyngeal leak pressure
Ambu AuraOnce
Device: Ambu AuraOnce
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).
Experimental: Fiberoptic position
Ambu AuraGain
Device: Ambu AuraGain
The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oropharyngeal leak pressure
Time Frame: 5 min
5 min

Secondary Outcome Measures

Outcome Measure
Time Frame
fiberoptic position
Time Frame: 5 min
5 min

Collaborators and Investigators

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

Sponsor

Schulthess Klinik

Collaborators

University of Salzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Schulthess_Anä_7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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