N/A
N=4,034
Evaluation of the Safety of C-Spine Clearance by Paramedics
Fracture of Cervical Spine
Bottom Line
View on ClinicalTrials.gov: NCT01188447 ↗Enrolled (actual)
4,034
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Adverse Events — 1 Adverse event
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Canadian C-Spine Rule (Procedure)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
1 | — |
| SECONDARY Clearance Rate |
2569 | — |
| SECONDARY Performance of the Canadian C-Spine Rule |
91 | — |
| SECONDARY Scene Time |
18 | — |
| SECONDARY Average Contact Time |
55 | — |
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) and transport them to the Emergency Department without immobilization. The specific objectives of the study are to determine safety, determine the clinical impact and evaluate performance.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01188447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.