Status:
COMPLETED
Evaluation of the Safety of C-Spine Clearance by Paramedics
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Fracture of Cervical Spine
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The goal of this cohort study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients with the Canadian C-Spine Rule (CCR) a...
Eligibility Criteria
Inclusion
- consecutive alert, stable adults evaluated by the paramedics with potential c-spine injury after sustaining acute blunt trauma. Patient eligibility will be determined at the time of paramedic arrival at the scene based on the following criteria:
- "Potential c-spine injury after sustaining acute blunt trauma" will include patients with either:
- neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior aspect of the neck),
- no neck pain but some visible injury above the clavicles, and/or
- neither neck pain nor visible injury, but significant mechanism of injury as determined by the paramedic at the scene.
- "Alert" is defined as a Glasgow Coma Scale score of 15 (converses, fully oriented, and follows commands).
- "Stable" refers to normal vital signs(systolic blood pressure 90 mm Hg or greater and respiratory rate between 10 and 24 breaths per minute).
- "Acute" refers to injury within the past 4 hours.
Exclusion
- Patients under the age of 16 years,
- Patients with penetrating trauma from stabbing or gunshot wound,
- Patients with acute paralysis (paraplegia, quadriplegia),
- Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery), or
- Patients referred from another hospital and transported between facilities.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
4034 Patients enrolled
Trial Details
Trial ID
NCT01188447
Start Date
January 1 2011
End Date
September 1 2015
Last Update
August 4 2017
Active Locations (1)
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1
Ottawa Paramedic Service
Ottawa, Ontario, Canada