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

Neck Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786966
• Other study ID #: CTO 0769
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: September 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6560
• Est. completion date: May 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neck Injuries

Intervention

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

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ontario Spor Support Unit

Country where clinical trial is conducted

Canada, 

Outcome

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