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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)

Primary Purpose

Head Trauma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
4-views series
2-views serie
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head Trauma focused on measuring Head trauma, Children, Radiography

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children who had a radiography for head trauma

Exclusion Criteria:

  • None

Sites / Locations

  • Sainte-Justine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4 views radiograph serie

2-view radiography serie

Arm Description

The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.

The 2-film series will include the following views: anterior-posterior and one lateral.

Outcomes

Primary Outcome Measures

Sensitivity
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
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
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.

Full Information

First Posted
October 5, 2011
Last Updated
March 18, 2013
Sponsor
St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01448473
Brief 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
Acronym
4vs2
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?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Trauma
Keywords
Head trauma, Children, Radiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 views radiograph serie
Arm Type
Experimental
Arm Description
The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.
Arm Title
2-view radiography serie
Arm Type
Active Comparator
Arm Description
The 2-film series will include the following views: anterior-posterior and one lateral.
Intervention Type
Other
Intervention Name(s)
4-views series
Intervention Description
The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.
Intervention Type
Other
Intervention Name(s)
2-views serie
Intervention Description
The 2-film series will include the following views: anterior-posterior and one lateral.
Primary Outcome Measure Information:
Title
Sensitivity
Description
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.
Title
Specificity
Description
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 Measure Information:
Title
Individual sensitivity
Description
The sensitivity of individual participants in the detection of skull fracture will be calculated.
Title
Individual specificity
Description
The specificity of individual participants in the detection of skull fracture will be calculated.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children who had a radiography for head trauma Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Gravel, MD
Organizational Affiliation
Sainte-Justine Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sainte-Justine Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada

12. IPD Sharing Statement

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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

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