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

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ClinicalTrials.gov Identifier: NCT00747981
Recruitment Status : Completed
First Posted : September 8, 2008
Last Update Posted : December 15, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Aspirated Foreign Body of Lower Respiratory Tract Procedure: Thoracic CT Scan Not Applicable

Detailed Description:
Comparison with gold standard diagnostic tool, the endoscopy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Management and Assessment of Thoracic CT Scan for Diagnosis of Aspirated Foreign Bodies in Children
Study Start Date : May 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Thoracic CT Scan
Procedure: Thoracic CT Scan
Perform a CT Scan and an endoscopy



Primary Outcome Measures :
  1. Comparison between CT Scan and endoscopy results [ Time Frame: 12 HOURS ]

Secondary Outcome Measures :
  1. X Ray radiation induced by CT Scan [ Time Frame: TWO YEARS ]


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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00747981     History of Changes
Other Study ID Numbers: K 070601
First Posted: September 8, 2008    Key Record Dates
Last Update Posted: December 15, 2011
Last Verified: August 2011

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

Additional relevant MeSH terms:
Foreign Bodies
Wounds and Injuries