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

Head Trauma Clinical Trial

— 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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448473
• Other study ID #: 4vs2
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: March 18, 2013
• Start date: October 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2013
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review BoardCanada: Ministère de la Santé et des Services Sociaux du Quebec
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children who had a radiography for head trauma

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Trauma
• Skull Fractures

Intervention

Other:
• 4-views series
The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.
• 2-views serie
The 2-film series will include the following views: anterior-posterior and one lateral.

Locations

Country	Name	City	State
Canada	Sainte-Justine Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Primary	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.		No
Secondary	Individual sensitivity	The sensitivity of individual participants in the detection of skull fracture will be calculated.		No
Secondary	Individual specificity	The specificity of individual participants in the detection of skull fracture will be calculated.