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

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Injuries
• Intervention / Treatment: Other: Canadian C-Spine Rule

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.

• Study Type: Interventional
• Enrollment (Actual): 6560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients transported with spinal immobilization	through study completion (one year)
Proportion of patients feeling comfortable	through study completion (one year)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a pain score </= 4/10		through study completion (one year)
Time from paramedic arrival at patient side to ED discharge or admission to hospital		through study completion (one year)
Radiation Exposure	radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit	through study completion (one year)
Number of skin pressure injuries		through study completion (one year)
Number of missed cervical spine injuries		through study completion (one year)
Paramedic Field Time (arrival at patient side until departure for hospital)	arrival at patient side until departure for hospital	through study completion (one year)
Paramedic Hospital Time	from arrival at emergency department to transfer of care to emergency department staff	through study completion (one year)
Subsequent emergency department visits or hospital admissions	within 30 days of initial visit	through study completion (one year)
Subsequent clinic or family physician visits	within 30 days of initial visit	through study completion (one year)
Frequency of Cervical Spine diagnostic imaging	at initial visit or within 30 days of initial visit	through study completion (one year)
Cost Savings	incremental cost saving per one immobilization avoided	through study completion (one year)

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: The Ontario Spor Support Unit
• Investigators: Principal Investigator: Christian Vaillancourt, MD, MSc, Ottawa Hospital Research Insitute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): April 30, 2018
• Study Completion (ACTUAL): May 31, 2018

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (ESTIMATE): June 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Emergency Medical Services; Paramedic; Cervical spine injuries; Canadian C-spine Rule; Cervical spine fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries
• Other Study ID Numbers: CTO 0769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No