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

December 14, 2011 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison with gold standard diagnostic tool, the endoscopy

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Paris V University & Assistance Publique Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Thoracic CT Scan
Procedure: Thoracic CT Scan
Perform a CT Scan and an endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison between CT Scan and endoscopy results
Time Frame: 12 HOURS
12 HOURS

Secondary Outcome Measures

Outcome Measure
Time Frame
X Ray radiation induced by CT Scan
Time Frame: TWO YEARS
TWO YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Yves MANACH, MD, HDR, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

December 15, 2011

Last Update Submitted That Met QC Criteria

December 14, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K 070601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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