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

NCT02786966 | Completed Results DMC

• 1 other identifier: CTO 0769
• Study Type: interventional
• Target: 3,646
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Injuries

Keywords

Cervical spine injuries; Canadian C-spine Rule; Emergency Medical Services; Paramedic; Cervical spine fracture

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients Transported With Spinal Immobilization

  Through study completion.

• Proportion of Patients Feeling Uncomfortable

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

  At study completion

Other Outcomes (11)

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

  At study completion

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

  At time of initial injury

• Radiation Exposure

  30 days from initial injury

Study Arms (1)

Control Phase

OTHER

Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).

Other: Canadian C-Spine Rule

Interventions

Canadian C-Spine Rule OTHER

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

Control Phase

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ontario Spor Support Unit: collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

• Vaillancourt C, Charette M, Taljaard M, Thavorn K, Hall E, McLeod B, Fergusson D, Brehaut J, Graham I, Calder L, Ramsay T, Tugwell P, Kelly P, Cheskes S, Saskin R, Plint A, Osmond M, Macarthur C, Straus S, Rochon P, Prud'homme D, Dahrouge S, Marlin S, Stiell IG. Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial. JMIR Res Protoc. 2020 Jun 1;9(6):e16966. doi: 10.2196/16966.

  PMID: 32348267 RESULT

MeSH Terms

Conditions

Neck Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Manya Charette
• Organization: Ottawa Hospital Research Institute

mancharette@ohri.ca

613-798-5555

Study Officials

• Christian Vaillancourt, MD, MSc

  Ottawa Hospital Research Insitute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 1, 2016
• Study Start: March 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 31, 2018
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)