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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014