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Is a Two-Film Skull X-ray Series as Sensitive as a Four-Film Series in the Diagnosis of Skull Fractures in Paediatric Patients (4vs2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01448473
First received: October 5, 2011
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

Minor head injuries are a common presenting complaint in the pediatric emergency department. Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. However, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. This study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians.


Condition Intervention
Head Trauma
 Other: 4-views series
Other: 2-views serie

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Is a Two-Film Skull X-ray Series as Sensitive as a Four-Film Series in the Diagnosis of Skull Fractures in Paediatric Patients With Minor Head Trauma?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Sensitivity [ Designated as safety issue: No ]
    The sensitivity is a simple proportion and will be measured by dividing the number of cases that were classified as positive for fracture by the total number of cases.

  • Specificity [ Designated as safety issue: No ]
    The specificity will be measured by dividing the number of x-rays of controls in which x-rays were read as negative by the total number of x-rays of controls.


Secondary Outcome Measures:
  • Individual sensitivity [ Designated as safety issue: No ]
    The sensitivity of individual participants in the detection of skull fracture will be calculated.

  • Individual specificity
    The specificity of individual participants in the detection of skull fracture will be calculated.


Enrollment: 14
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 views radiograph serie
The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.
 Other: 4-views series
The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.
Active Comparator: 2-view radiography serie
The 2-film series will include the following views: anterior-posterior and one lateral.
 Other: 2-views serie
The 2-film series will include the following views: anterior-posterior and one lateral.

Detailed Description:

Minor head injuries are a common presenting complaint in the pediatric emergency department. Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. However, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. This study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians.

This will be a prospective, crossover experimental study evaluating the equivalency in sensitivity and specificity of a 2-film series versus a 4-film series in the diagnosis of skull fracture associated with minor head injuries in children.

The study will involve 10 pediatric emergency physicians who will evaluate two modules of 100 series of radiography.

In order to do so, he or she will be given two work modules. Each module will contain the randomized and anonymous x-rays of the same 50 cases and 50 controls mounted on power point slides. Among the 50 cases, the evaluation sequence will be randomized such that 25 cases will be evaluated with the 2-film series in the first module and the 4-film series in the second module while the other 25 cases will evaluated in the reverse order. The same procedure will be used for randomizing the evaluation sequence of the 50 controls.

The primary outcomes will be the overall sensitivity and specificity of pediatric emergency medicine physicians for the detection of skull fractures using two evaluation methods: one in which they are presented with a skull series that has 2 views and another in which they are presented with a standard 4-view series.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children who had a radiography for head trauma

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448473

Locations
Canada, Quebec
Sainte-Justine Hospital
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Jocelyn Gravel, MD Sainte-Justine Hospital
  More Information

No publications provided

Responsible Party: Jocelyn Gravel, MD, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01448473     History of Changes
Other Study ID Numbers: 4vs2
Study First Received: October 5, 2011
Last Updated: March 18, 2013
Health Authority: Canada: Institutional Review Board
Canada: Ministère de la Santé et des Services Sociaux du Quebec

Keywords provided by St. Justine's Hospital:
Head trauma
Children
Radiography

Additional relevant MeSH terms:
Craniocerebral Trauma
Skull Fractures
Wounds and Injuries
 Trauma, Nervous System
Nervous System Diseases
Fractures, Bone

ClinicalTrials.gov processed this record on May 16, 2013