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Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies. (SICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00747981
First received: September 5, 2008
Last updated: December 14, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention
Aspirated Foreign Body of Lower Respiratory Tract
 Procedure: Thoracic CT Scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Management and Assessment of Thoracic CT Scan for Diagnosis of Aspirated Foreign Bodies in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Comparison between CT Scan and endoscopy results [ Time Frame: 12 HOURS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • X Ray radiation induced by CT Scan [ Time Frame: TWO YEARS ] [ Designated as safety issue: Yes ]

Enrollment: 311
Study Start Date: May 2008
Study Completion Date: October 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Thoracic CT Scan
 Procedure: Thoracic CT Scan
Perform a CT Scan and an endoscopy
Other Name: Thoracic CT Scan

Detailed Description:

Comparison with gold standard diagnostic tool, the endoscopy

  Eligibility

Ages Eligible for Study:   6 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747981

Locations
France
Paris V University & Assistance Publique Hôpitaux de Paris
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yves MANACH, MD, HDR Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00747981     History of Changes
Other Study ID Numbers: K 070601
Study First Received: September 5, 2008
Last Updated: December 14, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
CT Scan
Endoscopy
Aspiration
Foreign Bodies

Additional relevant MeSH terms:
Foreign Bodies
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013