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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02786966
Enrollment
3646
Registered
2016-06-01
Start date
2017-03-01
Completion date
2018-05-31
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Injuries

Keywords

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

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.

Interventions

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

Sponsors

The Ontario Spor Support Unit
CollaboratorOTHER
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients Transported With Spinal ImmobilizationThrough study completion.
Proportion of Patients Feeling UncomfortableAt study completionMeasured on an ordinal scale from 1 to 10, with higher values indicating increasing discomfort. Values \>=5 were considered to indicate discomfort.

Other

MeasureTime frameDescription
Radiation Exposure30 days from initial injuryradiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit
Number of Skin Pressure Injuriesthrough study completion (one year)
Number of Missed Cervical Spine Injuriesthrough study completion (one year)
Paramedic Field Time (Arrival at Patient Side Until Departure for Hospital)at time of initial injuryarrival at patient side until departure for hospital
Proportion of Patients With a Pain Score </= 5/10At study completionMeasured on a 10-point ordinal scale with increasing values indicating greater pain.
Subsequent Emergency Department Visits or Hospital Admissionsthrough study completion (one year)within 30 days of initial visit
Subsequent Clinic or Family Physician Visitswithin 30 days of initial injurywithin 30 days of initial visit
Frequency of Cervical Spine Diagnostic Imagingwithin 30 days of initial injuryat initial visit or within 30 days of initial visit
Cost Savingsthrough study completion (one year)incremental cost saving per one immobilization avoided
Paramedic Hospital Timethrough study completion (one year)from arrival at emergency department to transfer of care to emergency department staff
Time From Paramedic Arrival at Patient Side to ED Discharge or Admission to HospitalAt time of initial injuryTime from paramedic arrival at patient side to ED discharge or admission to hospital

Countries

Canada

Participant flow

Participants by arm

ArmCount
Control Phase (Usual Care)
Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule, but spinal immobilization using standard immobilization protocols (usual care).
1,745
Canadian C-Spine Rule
Assessment using Canadian C-Spine Rule to determine need for spinal immobilization for transport.
1,901
Total3,646

Baseline characteristics

CharacteristicCanadian C-Spine RuleTotalControl Phase (Usual Care)
Age, Continuous46.5 years
STANDARD_DEVIATION 21.9
47.2 years
STANDARD_DEVIATION 21
48.0 years
STANDARD_DEVIATION 21.9
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Canada
1901 participants3646 participants1745 participants
Sex: Female, Male
Female
998 Participants1874 Participants876 Participants
Sex: Female, Male
Male
903 Participants1772 Participants869 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,7450 / 1,898
other
Total, other adverse events
0 / 1,7450 / 1,898
serious
Total, serious adverse events
0 / 1,7450 / 1,898

Outcome results

Primary

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.

Time frame: At study completion

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Phase (Usual Care)Proportion of Patients Feeling Uncomfortable883 Participants
Canadian C-Spine RuleProportion of Patients Feeling Uncomfortable654 Participants
p-value: 0.000795% CI: [0.47, 0.8]Regression, Logistic
Primary

Proportion of Patients Transported With Spinal Immobilization

Time frame: Through study completion.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Phase (Usual Care)Proportion of Patients Transported With Spinal Immobilization1334 Participants
Canadian C-Spine RuleProportion of Patients Transported With Spinal Immobilization813 Participants
p-value: 0.000795% CI: [0.2, 0.6]Regression, Logistic
Other Pre-specified

Cost Savings

incremental cost saving per one immobilization avoided

Time frame: through study completion (one year)

Other Pre-specified

Frequency of Cervical Spine Diagnostic Imaging

at initial visit or within 30 days of initial visit

Time frame: within 30 days of initial injury

Other Pre-specified

Number of Missed Cervical Spine Injuries

Time frame: through study completion (one year)

Other Pre-specified

Number of Skin Pressure Injuries

Time frame: through study completion (one year)

Other Pre-specified

Paramedic Field Time (Arrival at Patient Side Until Departure for Hospital)

arrival at patient side until departure for hospital

Time frame: at time of initial injury

Other Pre-specified

Paramedic Hospital Time

from arrival at emergency department to transfer of care to emergency department staff

Time frame: through study completion (one year)

Other Pre-specified

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

Measured on a 10-point ordinal scale with increasing values indicating greater pain.

Time frame: At study completion

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Phase (Usual Care)Proportion of Patients With a Pain Score </= 5/10866 Participants
Canadian C-Spine RuleProportion of Patients With a Pain Score </= 5/10736 Participants
p-value: 0.009395% CI: [0.52, 0.91]Regression, Logistic
Other Pre-specified

Radiation Exposure

radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit

Time frame: 30 days from initial injury

Other Pre-specified

Subsequent Clinic or Family Physician Visits

within 30 days of initial visit

Time frame: within 30 days of initial injury

Other Pre-specified

Subsequent Emergency Department Visits or Hospital Admissions

within 30 days of initial visit

Time frame: through study completion (one year)

Other Pre-specified

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

Time from paramedic arrival at patient side to ED discharge or admission to hospital

Time frame: At time of initial injury

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026