Evaluation of the Safety of C-Spine Clearance by Paramedics

Ottawa Hospital Research Institute

Status: Completed

Conditions: Fracture of Cervical Spine

Treatments: Procedure: Canadian C-Spine Rule

Study type: Interventional

Funder types: Other

Identifiers

NCT01188447

2009142-01H

Details and patient eligibility

About

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.

Enrollment: 4,034 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,034 participants in 1 patient group

Eligible low-risk trauma patients

Experimental group

Description:

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.

Treatment:

Procedure: Canadian C-Spine Rule