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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00747981
First Posted: September 8, 2008
Last Update Posted: December 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
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

Resource links provided by NLM:


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 ]

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

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

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

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00747981     History of Changes
Other Study ID Numbers: K 070601
First Submitted: September 5, 2008
First Posted: September 8, 2008
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