Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.

Aspirated Foreign Body of Lower Respiratory Tract Clinical Trial

— SICE  

Official title:

Management and Assessment of Thoracic CT Scan for Diagnosis of Aspirated Foreign Bodies in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747981
• Other study ID #: K 070601
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: December 14, 2011
• Start date: May 2008
• Est. completion date: October 2011

Study information

• Verified date: August 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To access CT Scan as a diagnostic tool for foreign bodies aspiration.

Description:

Comparison with gold standard diagnostic tool, the endoscopy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: October 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 16 Years

Eligibility

Inclusion Criteria:

• age between 6 months and 16 years

• suspicion of a foreign body aspiration

• health care assurance

• information of parents

Exclusion Criteria:

• emergency situation

• certainly of foreign body presence

• delay for CT Scan realization longer than 24 hours

• no speaking French parents

• parents refusal.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aspirated Foreign Body of Lower Respiratory Tract
• Foreign Bodies

Intervention

Procedure:
• Thoracic CT Scan
Perform a CT Scan and an endoscopy

Locations

Country	Name	City	State
France	Paris V University & Assistance Publique Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between CT Scan and endoscopy results		12 HOURS	Yes
Secondary	X Ray radiation induced by CT Scan		TWO YEARS	Yes