Evaluation of the Safety of C-Spine Clearance by Paramedics

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Safety of C-Spine Clearance by Paramedics

Conditions
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Fracture of Cervical Spine

Intervention / Treatment
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* Procedure: Canadian C-Spine Rule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eligible low-risk trauma patients<br>Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital. | Procedure: Canadian C-Spine Rule<br>* Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Measures of safety will include: number of missed cervical spine injuries number of serious adverse outcomes | within 30 days of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance Rate | Proportion of eligible low-risk patients transported without immobilization | Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit | 
| Performance of the Canadian C-Spine Rule | Measurements of the performance of the rule will include: rule accuracy paramedic accuracy of interpretation paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule | Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment. | 
| Scene Time | Time spent at scene (difference between Paramedic scene departure and arrival at patient side) | immediately following evaluation | 
| Average Contact Time | Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side) | immediately following evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical-spine injuries, cervical-spine fractures, spinal cord injury, neck injury, Canadian C-Spine Rule, paramedics, emergency medical services