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Laryngeal Mask Ambu Aura Once vs. Supreme in Children

This study has been withdrawn prior to enrollment.
(Other studies with the same protocol have already published.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718782
First Posted: October 31, 2012
Last Update Posted: May 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Paal, Medical University Innsbruck
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children

Further study details as provided by Peter Paal, Medical University Innsbruck:

Primary Outcome Measures:
  • Leakage pressure [cmH2O] [ Time Frame: 1min ]
    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 ]
    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 ]
  • stomach insufflation [yes or no] [ Time Frame: 3 minutes ]

Enrollment: 0
Study Start Date: March 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718782


Locations
Austria
University Hospital Innsbruck
Innsbruck, Tirol, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Peter Paal, MD,DESA,EDIC University Hospital Innsbruck, Department of Anaesthesia + Intensive Care
  More Information

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
First Submitted: September 27, 2012
First Posted: October 31, 2012
Last Update Posted: May 15, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants