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Laryngeal Mask Ambu Aura Once vs. Supreme in Children

This study is currently recruiting participants.
Verified March 2013 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Peter Paal, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01718782
First received: September 27, 2012
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Apnea
 Device: laryngeal mask Ambu AuraOnce
Device: laryngeal mask LMA Supreme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Leakage pressure [cmH2O] [ Time Frame: 1min ] [ Designated as safety issue: Yes ]
    After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation


Secondary Outcome Measures:
  • Efficient ventilation [mL], [ Time Frame: 3min ] [ Designated as safety issue: Yes ]
    After ventilation has been established the efficient ventilation, tidal volume and stomach inflation will be measured, ie 3min after establishing ventilation

  • tidal volume [mL], [ Time Frame: 3 minutes ] [ Designated as safety issue: Yes ]
  • stomach insufflation [yes or no] [ Time Frame: 3 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: laryngeal mask Ambu AuraOnce
laryngeal mask Ambu AuraOnce
 Device: laryngeal mask Ambu AuraOnce
airway management and mechanical ventilation with laryngeal mask
Active Comparator: laryngeal mask LMA Supreme
laryngeal mask LMA Supreme
 Device: laryngeal mask LMA Supreme
airway management and mechanical ventilation with laryngeal mask

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

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718782

Contacts
Contact: Peter Paal, MD,DESA,EDIC +4351250480448 peter.paal@uki.at

Locations
Austria
University Hospital Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Peter Paal, MD     +4351250480448     peter.paal@uki.at    
Principal Investigator: Peter Paal, MD            
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Peter Paal, MD,DESA,EDIC University Hospital Innsbruck, Department of Anaesthesia + Intensive Care
  More Information

No publications provided

Responsible Party: Peter Paal, Peter Paal, MD, DESA, EDIC, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01718782     History of Changes
Other Study ID Numbers: AN4111 292/4.23
Study First Received: September 27, 2012
Last Updated: March 12, 2013
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University Innsbruck:
laryngeal mask, leakage pressure, ventilation

Additional relevant MeSH terms:
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013