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Completed

NCT Number: NCT01188447

Evaluation of the Safety of C-Spine Clearance by Paramedics

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.

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Key information

Conditions

Fracture of Cervical Spine Central Nervous System Diseases Neck Injuries Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ottawa Paramedic Service

Ottawa, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Canadian C-Spine Rule

Procedure

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.

Primary outcomes

  1. Adverse Events

    Time frame: within 30 days of enrollment

    Measures of safety will include:

    • number of missed cervical spine injuries
    • number of serious adverse outcomes

Secondary outcomes

  1. Clearance Rate

    Time frame: Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit

    Proportion of eligible low-risk patients transported without immobilization

  2. Performance of the Canadian C-Spine Rule

    Time frame: Rule 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:

    • rule accuracy
    • paramedic accuracy of interpretation
    • paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule

  3. Scene Time

    Time frame: immediately following evaluation

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

  4. Average Contact Time

    Time frame: immediately following evaluation

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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2010
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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