Airway Anatomy of the SimBaby

Airway Reality Clinical Trial

Official title:

A Comparison of Pediatric Airway Anatomy With the SimBaby High-Fidelity Simulator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147783
• Other study ID #: Anae-Vie-SimbabyCT
• Status: Completed
• Phase: N/A
• First received: June 17, 2010
• Last updated: July 2, 2010
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: June 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 12 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Airway Reality

Intervention

Other:
• CT, MRI

Locations

Country	Name	City	State
Austria	Medical University of vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharyngeal measurements			No
Secondary	anatomic structures of the upper airway	distances, volumes and cross sectional areas of the tongue, soft palat, pharyngeal structures as well as oral airspace		No