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

NCT ID: NCT02786966

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3646 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-05-31

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.

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.

Conditions

Neck Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control Phase

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

Group Type: OTHER

Canadian C-Spine Rule

Intervention Type: OTHER

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

Interventions

Canadian C-Spine Rule

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ontario Spor Support Unit

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Vaillancourt, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Insitute

Locations

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 32348267 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CTO 0769

Identifier Type: -

Identifier Source: org_study_id