Clinical trial NCT01448473: Is a Two-Film Skull X-ray Series as Sensitive as a Four-Film Series in the Diagnosis of Skull Fractures in Paediatric Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Head Trauma
Keywords: Head trauma
Children
Radiography
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 14
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Children who had a radiography for head trauma

Exclusion Criteria:

* None

Primary outcomes:
measure: Sensitivity
measure: Specificity
Secondary outcomes:
measure: Individual sensitivity
measure: Individual specificity
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Sainte-Justine Hospital
state: Quebec
Study officials:
affiliation: Sainte-Justine Hospital
name: Jocelyn Gravel, MD
role: PRINCIPAL_INVESTIGATOR
References: