- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01147783
Airway Anatomy of the SimBaby
July 2, 2010 updated by: Medical University of Vienna
A Comparison of Pediatric Airway Anatomy With the SimBaby High-Fidelity Simulator
The aim of the present study is to compare radiographic upper airway measurements of the SimBabyTM pediatric patient high-fidelity simulator with actual human airway anatomy to assess the grade of realism of the simulator.
Study Overview
Study Type
Observational
Enrollment (Actual)
20
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
-
-
-
Vienna, Austria, 1090
- Medical University of Vienna
-
-
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 month to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
infants undergoing routine head MRI
Description
Inclusion Criteria:
- MRI or CT head or neck including upper airway
- age: 1-12 months
Exclusion Criteria:
- no pathology of airway, face, neck
- no airway device in place
- head not in neutral position
- neck collar
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SimBaby
|
|
|
Infants (1-12 mo)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
pharyngeal measurements
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
|---|---|
|
anatomic structures of the upper airway
|
distances, volumes and cross sectional areas of the tongue, soft palat, pharyngeal structures as well as oral airspace
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oliver Kimberger, M.D., P.D., Medical University of Vienna, Dept. of. Anesthesia, General Intensive Care and Pain Management
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
November 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 17, 2010
First Submitted That Met QC Criteria
June 18, 2010
First Posted (Estimate)
June 22, 2010
Study Record Updates
Last Update Posted (Estimate)
July 5, 2010
Last Update Submitted That Met QC Criteria
July 2, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- Anae-Vie-SimbabyCT
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.