MRI Review of Tracheal Dimensions

This study has been terminated.
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00277953
First received: January 13, 2006
Last updated: May 2, 2007
Last verified: May 2007
  Purpose

To date, there have been no published reports of normal variations in tracheal dimensions for pediatric patients undergoing MRIs. While there are reports of normals in CT studies, the reported dimensions were for average areas and lengths over the entire length of the trachea and not for normal variation in the dimensions at various sites in the trachea. Moreover, CT measurements are likely not entirely applicable to MRI measurements. Since cardiac MRI has become the procedure of choice to document the presence of vascular rings as well as the significance of any ring that is found, there is a need for normal values to be generated. This would in turn permit physicians to determine in cases of documented vascular rings the severity of the tracheal stenosis/deformity if found.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: A Review of Tracheal Dimensions in the Pediatric Population Using MRI

Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 75
Detailed Description:

To date, there have been no published reports of normal variations in tracheal dimensions for pediatric patients undergoing MRIs. While there are reports of normals in CT studies, the reported dimensions were for average areas and lengths over the entire length of the trachea and not for normal variation in the dimensions at various sites in the trachea. Moreover, CT measurements are likely not entirely applicable to MRI measurements. Since cardiac MRI has become the procedure of choice to document the presence of vascular rings as well as the significance of any ring that is found, there is a need for normal values to be generated. This would in turn permit physicians to determine in cases of documented vascular rings the severity of the tracheal stenosis/deformity if found.

Hypothesis: Patients referred for cardiac MRIs to evaluate vascular rings will have significantly smaller tracheal dimensions (area, longest width, shortest width) based on a percentage of their maximal tracheal dimension in comparison with patients referred for cardiac MRIs for other indications.

I would propose to retrospectively review cardiac MRIs for tracheal dimensions in 25 consecutive patients referred for possible vascular rings and for 50 consecutive patients undergoing cardiac MRIs for other indications. As part of this study I would also propose to review the clinical findings that prompted the cardiac MRI to be ordered (i.e. respiratory symptoms, abnormal echocardiogram, abnormal CXR or barium swallow).

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 25 consecutive patients referred for possible vascular rings 50 consecutive patients undergoing cardiac MRIs for other indications adequate axial double-inversion recovery images of sufficient quality to permit accurate measurement of variations in tracheal dimension.

Exclusion Criteria:

  • Those who do not meet inclusion criteria
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00277953

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Denver Sallee III, MD Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00277953     History of Changes
Other Study ID Numbers: 04-047
Study First Received: January 13, 2006
Last Updated: May 2, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
Pediatric
Cardiac
Tracheal Dimensions
MRI

ClinicalTrials.gov processed this record on August 21, 2014