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

NCT ID: NCT01448473

Last Updated: 2013-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-02-29

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.

Conditions

Head Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

4 views radiograph serie

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

Group Type: EXPERIMENTAL

4-views series

Intervention Type: OTHER

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

2-view radiography serie

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

Group Type: ACTIVE_COMPARATOR

2-views serie

Intervention Type: OTHER

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

Interventions

4-views series

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

Intervention Type: OTHER

2-views serie

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children who had a radiography for head trauma

Exclusion Criteria

• None

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jocelyn Gravel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jocelyn Gravel, MD

Role: PRINCIPAL_INVESTIGATOR

Sainte-Justine Hospital

Locations

Sainte-Justine Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

4vs2

Identifier Type: -

Identifier Source: org_study_id