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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786966
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
The Ontario Spor Support Unit
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Neck Injuries Other: Canadian C-Spine Rule Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6560 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Canadian C-Spine Rule
Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule
Other: Canadian C-Spine Rule
Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule




Primary Outcome Measures :
  1. Proportion of patients transported with spinal immobilization [ Time Frame: through study completion (one year) ]
  2. Proportion of patients feeling comfortable [ Time Frame: through study completion (one year) ]

Other Outcome Measures:
  1. Proportion of patients with a pain score </= 4/10 [ Time Frame: through study completion (one year) ]
  2. Time from paramedic arrival at patient side to ED discharge or admission to hospital [ Time Frame: through study completion (one year) ]
  3. Radiation Exposure [ Time Frame: through study completion (one year) ]
    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: through study completion (one year) ]
    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: through study completion (one year) ]
    within 30 days of initial visit

  10. Frequency of Cervical Spine diagnostic imaging [ Time Frame: through study completion (one year) ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786966


Locations
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Canada, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Ontario Spor Support Unit
Investigators
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Principal Investigator: Christian Vaillancourt, MD, MSc Ottawa Hospital Research Insitute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02786966    
Other Study ID Numbers: CTO 0769
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Cervical spine injuries
Canadian C-spine Rule
Emergency Medical Services
Paramedic
Cervical spine fracture
Additional relevant MeSH terms:
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Neck Injuries
Wounds and Injuries