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Evaluation of the Safety of C-Spine Clearance by Paramedics

Not Applicable
Completed
Conditions
Fracture of Cervical Spine
Interventions
Procedure: Canadian C-Spine Rule
Registration Number
NCT01188447
Lead Sponsor
Ottawa Hospital Research Institute
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) 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4034
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Eligible low-risk trauma patientsCanadian C-Spine RuleParamedics 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.
Primary Outcome Measures
NameTimeMethod
Adverse Eventswithin 30 days of enrollment

Measures of safety will include:

1. number of missed cervical spine injuries

2. number of serious adverse outcomes

Secondary Outcome Measures
NameTimeMethod
Clearance RateMeasures of clinical impact will be assessed immediately following the patient's Emergency Department visit

Proportion of eligible low-risk patients transported without immobilization

Performance of the Canadian C-Spine RuleRule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.

Measurements of the performance of the rule will include:

1. rule accuracy

2. paramedic accuracy of interpretation

3. paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule

Scene Timeimmediately following evaluation

Time spent at scene (difference between Paramedic scene departure and arrival at patient side)

Average Contact Timeimmediately following evaluation

Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)

Trial Locations

Locations (1)

Ottawa Paramedic Service

🇨🇦

Ottawa, Ontario, Canada

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