Study Stopped
Other studies with the same protocol have already published.
Laryngeal Mask Ambu Aura Once vs. Supreme in Children
Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 15, 2014
May 1, 2014
1.2 years
September 27, 2012
May 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Leakage pressure [cmH2O]
After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation
1min
Secondary Outcomes (3)
Efficient ventilation [mL],
3min
tidal volume [mL],
3 minutes
stomach insufflation [yes or no]
3 minutes
Study Arms (2)
laryngeal mask Ambu AuraOnce
ACTIVE COMPARATORlaryngeal mask Ambu AuraOnce
laryngeal mask LMA Supreme
ACTIVE COMPARATORlaryngeal mask LMA Supreme
Interventions
airway management and mechanical ventilation with laryngeal mask
airway management and mechanical ventilation with laryngeal mask
Eligibility Criteria
You may qualify if:
- Children aged 1-10 years
- ASA I - III
- Elective procedure in general anaesthesia
- Parental informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Innsbruck
Innsbruck, Tyrol, 6020, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Paal, MD,DESA,EDIC
University Hospital Innsbruck, Department of Anaesthesia + Intensive Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Peter Paal, MD, DESA, EDIC
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 31, 2012
Study Start
March 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 15, 2014
Record last verified: 2014-05