- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02811042
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
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Bozen, Italy, 39100
- Zentralkrankenhaus Bozen
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-
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Zürich, Switzerland, 8008
- Christian Keller MD, M.Sc.
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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
|
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).
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Experimental: Fiberoptic position
Ambu AuraGain
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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
Collaborators
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.
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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