Status:
COMPLETED
Implementation of the Canadian C-Spine Rule
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cspine Injury
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
Many thousands of trauma patients are seen in Canadian emergency departments each year. On rare occasions, such patients have a broken neck (cervical spine fracture) but in 98 percent of cases the xra...
Detailed Description
Background: Physicians in Canadian emergency departments (EDs) annually treat 185,000 alert and stable trauma victims who are at risk for cervical spine (c-spine) injury. Only 0.9% of these patients h...
Eligibility Criteria
Inclusion
- All alert, stable adults presenting to the study hospital EDs after sustaining acute blunt trauma to the head or neck will be eligible and consecutive eligible trauma patients will be entered into the study. Patient eligibility will be determined based on these criteria at the time of arrival in the ED. a) "Trauma to the head and neck" will include patients with either: i) neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior midline or posterolateral aspect of the neck), or ii) no neck pain but all of: some visible injury above the clavicles, has not been ambulatory at any time, and associated with a high risk mechanism of injury (motor vehicle collision including motorcycle, pedestrian struck by a motor vehicle, bicycle collision, fall greater than or equal to 3 feet or 5 steps, diving, or contact sport with axial load to head and neck). b) "Alert" is defined as a Glasgow Coma Scale103 score of 15 (converses, fully oriented, and follows commands). c) "Stable" refers to normal vital signs as defined by the Revised Trauma Score24 (systolic blood pressure 90 mm Hg or greater and respiratory rate between 10 and 24 breaths per minute). d) "Acute" refers to injury within the past 48 hours.
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Exclusion
- a) Patients under the age of 16 years, b) Patients who do not satisfy the definition of "trauma to the head and neck" as defined above (for example, patients with neither neck pain nor visible injuries above the clavicles will be excluded), c) Patients with Glasgow Coma Scale score less than 15, d) Patients with unstable vital signs (systolic BP \< 90; respiratory rate less than 10 or more than 24), e) Patients whose injury occurred more than 48 hours previously, f) Patients with penetrating trauma from stabbing or gunshot wound, g) Patients with acute paralysis (paraplegia, quadriplegia), h) Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery), or i) Patients who return for reassessment of the same injury.
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Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
11824 Patients enrolled
Trial Details
Trial ID
NCT00290875
Start Date
January 1 2003
End Date
January 1 2008
Last Update
April 22 2015
Active Locations (1)
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1
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9