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NCT Number: NCT02786966

A Pragmatic Evaluation of the Canadian C-Spine Rule by Paramedics

Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (ED). Less than 1% of all these patients actually have a neck bone fracture. Even less (0.5%) have a spinal cord injury or nerve damage. These injuries usually occur at the time of initial trauma and not during transport to the ED. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, collar, and head immobilizers. Trauma victims can stay immobilized for hours until an ED bed is made available or until x-rays are completed. Importantly, long immobilization is often unnecessary, it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly.

The investigators developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury.

The investigators will evaluate the possibility and benefits of allowing paramedics to use the CCR in the field in 12 new communities from across Ontario. Patients have suggested the investigators include measures of pain and discomfort from being immobilized during transport as important patient-centred outcomes. The investigators will also measure the impact on the ED, and how much money could be saved if more paramedics were allowed to use the CCR. The investigators will also assess if sex, age, language barriers, or living far from the hospital (long transport time) will affect the outcomes of the study.

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Key information

Conditions

Neck Injuries Wounds and Injuries

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

About this study

Paramedics in participating Ontario communities will all receive standardized training on the application of the Canadian C-Spine Rule (CCR). Once the training has been completed, paramedics will begin using the CCR to evaluate patients with potential c-spine injuries. For the first three months of the evaluation period, paramedics will use the CCR to evaluate eligible patients, but continue to use spinal immobilization for transport according to their existing protocols. After this validation period, participating services will be randomized in stepped wedge fashion in clusters of 4 services to actively use the CCR and selectively immobilize according to the CCR.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Alert (Glasgow Coma Scale 15)
  • Stable: Adult (16+): systolic blood pressure greater than or equal to 90 mmHg, respiratory rate 10-24 breaths/minute; Child (8-15): systolic blood pressure greater than or equal to 90 mmHg + (2 X age in years), respiratory rate 14-20 breaths/minute
  • Acute blunt injury (within 48 hours of paramedic contact)

Exclusion criteria

  • Age <8 years of age
  • Penetrating trauma from stabbing or gunshot wound
  • Acute paralysis (paraplegia, quadriplegia)
  • Known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, previous c-spine surgery)
  • Referred from another hospital

Treatment and study plan

Canadian C-Spine Rule

Other

Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule

Primary outcomes

  1. Proportion of Patients Transported With Spinal Immobilization

    Time frame: Through study completion.

  2. Proportion of Patients Feeling Uncomfortable

    Time frame: At study completion

    Measured on an ordinal scale from 1 to 10, with higher values indicating increasing discomfort. Values >=5 were considered to indicate discomfort.

Other outcomes

  1. Proportion of Patients With a Pain Score </= 5/10

    Time frame: At study completion

    Measured on a 10-point ordinal scale with increasing values indicating greater pain.

  2. Time From Paramedic Arrival at Patient Side to ED Discharge or Admission to Hospital

    Time frame: At time of initial injury

    Time from paramedic arrival at patient side to ED discharge or admission to hospital

  3. Radiation Exposure

    Time frame: 30 days from initial injury

    radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit

  4. Number of Skin Pressure Injuries

    Time frame: through study completion (one year)

  5. Number of Missed Cervical Spine Injuries

    Time frame: through study completion (one year)

  6. Paramedic Field Time (Arrival at Patient Side Until Departure for Hospital)

    Time frame: at time of initial injury

    arrival at patient side until departure for hospital

  7. Paramedic Hospital Time

    Time frame: through study completion (one year)

    from arrival at emergency department to transfer of care to emergency department staff

  8. Subsequent Emergency Department Visits or Hospital Admissions

    Time frame: through study completion (one year)

    within 30 days of initial visit

  9. Subsequent Clinic or Family Physician Visits

    Time frame: within 30 days of initial injury

    within 30 days of initial visit

  10. Frequency of Cervical Spine Diagnostic Imaging

    Time frame: within 30 days of initial injury

    at initial visit or within 30 days of initial visit

  11. Cost Savings

    Time frame: through study completion (one year)

    incremental cost saving per one immobilization avoided

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • The Ontario Spor Support Unit

Registry information

Official study title

A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2016
Registry last updated
Oct 20, 2025

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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