Airway RealityNCT01147783
Airway Anatomy of the SimBaby
An observational study of Airway Reality, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Airway Reality
- What is being tested?
- CT, MRI
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2008to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants undergoing routine head MRI
Who may be able to join
- MRI or CT head or neck including upper airway
- age: 1-12 months
Who cannot join
- no pathology of airway, face, neck
- no airway device in place
- head not in neutral position
- neck collar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Airway Reality
- Being tested
- CT, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT, MRIOther
| Study group | Role | What they receive |
|---|---|---|
| SimBaby | Not described Receives: Other: CT, MRI | |
| Infants (1-12 mo) | Not described Receives: Other: CT, MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharyngeal measurements
Secondary outcomes (1)
anatomic structures of the upper airway
distances, volumes and cross sectional areas of the tongue, soft palat, pharyngeal structures as well as oral airspace
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway RealityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Oliver Kimberger, M.D., P.D., Principal investigator, Medical University of Vienna, Dept. of. Anesthesia, General Intensive Care and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147783
- Sponsor's protocol ID
- Anae-Vie-SimbabyCT
- Status last verified
- Jun 2010
- First submitted
- 17 Jun 2010
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Schebesta K, Hupfl M, Ringl H, Machata AM, Chiari A, Kimberger O. A comparison of paediatric airway anatomy with the SimBaby high-fidelity patient simulator. Resuscitation. 2011 Apr;82(4):468-72. doi: 10.1016/j.resuscitation.2010.12.001. Epub 2011 Jan 14.
PubMed 21237552
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pediatric Airway Anatomy With the SimBaby High-Fidelity Simulator
- ClinicalTrials.gov ID
- NCT01147783
- Acronym / sponsor ID
- Anae-Vie-SimbabyCT
- Conditions
- Airway Reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SimBaby | – | Other: CT, MRI |
| Infants (1-12 mo) | – | Other: CT, MRI |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants undergoing routine head MRI
Key inclusion criteria (2 listed)
- MRI or CT head or neck including upper airway
- age: 1-12 months
Key exclusion criteria (4 listed)
- no pathology of airway, face, neck
- no airway device in place
- head not in neutral position
- neck collar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT, MRI | Other | Infants (1-12 mo), SimBaby |
Primary outcome
pharyngeal measurements
1 secondary outcome
anatomic structures of the upper airway
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
- Derived from this study: PubMed 21237552Schebesta K, Hupfl M, Ringl H, Machata AM, Chiari A, Kimberger O. A comparison of paediatric airway anatomy with the SimBaby high-fidelity patient simulator. Resuscitation. 2011 Apr;82(4):468-72. doi: 10.1016/j.resuscitation.2010.12.001. Epub 2011 Jan 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Kimberger, M.D., P.D. principal investigator
Medical University of Vienna, Dept. of. Anesthesia, General Intensive Care and Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Reality, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharyngeal measurements. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2010.