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
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 5, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMarch 19, 2013
March 1, 2013
2 months
October 5, 2011
March 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Individual sensitivity
Individual specificity
Study Arms (2)
4 views radiograph serie
EXPERIMENTALThe 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.
2-view radiography serie
ACTIVE COMPARATORThe 2-film series will include the following views: anterior-posterior and one lateral.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children who had a radiography for head trauma
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sainte-Justine Hospital
Montreal, Quebec, H3T1C5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jocelyn Gravel, MD
Sainte-Justine Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 5, 2011
First Posted
October 7, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
March 19, 2013
Record last verified: 2013-03