Clinical trial NCT01188447: Evaluation of the Safety of C-Spine Clearance by Paramedics
Official title: Evaluation of the Safety of C-Spine Clearance by Paramedics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture of Cervical Spine
Keywords: cervical-spine injuries
cervical-spine fractures
spinal cord injury
neck injury
Canadian C-Spine Rule
paramedics
emergency medical services
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-08-25
Enrollment: 4034
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Adverse Events
timeFrame: within 30 days of enrollment
Secondary outcomes:
measure: Clearance Rate
timeFrame: Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit
measure: Performance of the Canadian C-Spine Rule
timeFrame: Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.
measure: Scene Time
timeFrame: immediately following evaluation
measure: Average Contact Time
timeFrame: immediately following evaluation
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Paramedic Service
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Christian Vaillancourt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaillancourt C, Charette M, Kasaboski A, Maloney J, Wells GA, Stiell IG. Evaluation of the safety of C-spine clearance by paramedics: design and methodology. BMC Emerg Med. 2011 Feb 1;11:1. doi: 10.1186/1471-227X-11-1.