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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

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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01448473
Acronym
4vs2
Enrollment
14
Registered
2011-10-07
Start date
2011-10-31
Completion date
2012-02-29
Last updated
2013-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Trauma

Keywords

Head trauma, Children, Radiography

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.

Interventions

OTHER4-views series

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

OTHER2-views serie

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

Sponsors

St. Justine's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Children who had a radiography for head trauma

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
SensitivityThe 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.
SpecificityThe 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

MeasureTime frameDescription
Individual sensitivityThe sensitivity of individual participants in the detection of skull fracture will be calculated.
Individual specificityThe specificity of individual participants in the detection of skull fracture will be calculated.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026