Neck Injuries
Conditions
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
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Transported With Spinal Immobilization | Through study completion. | — |
| Proportion of Patients Feeling Uncomfortable | At study completion | Measured on an ordinal scale from 1 to 10, with higher values indicating increasing discomfort. Values \>=5 were considered to indicate discomfort. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Radiation Exposure | 30 days from initial injury | radiation exposure from diagnostic imaging tests of the spine conducted at initial visit or within 30 days of the initial visit |
| 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) | at time of initial injury | arrival at patient side until departure for hospital |
| Proportion of Patients With a Pain Score </= 5/10 | At study completion | Measured on a 10-point ordinal scale with increasing values indicating greater pain. |
| Subsequent Emergency Department Visits or Hospital Admissions | through study completion (one year) | within 30 days of initial visit |
| Subsequent Clinic or Family Physician Visits | within 30 days of initial injury | within 30 days of initial visit |
| Frequency of Cervical Spine Diagnostic Imaging | within 30 days of initial injury | at initial visit or within 30 days of initial visit |
| Cost Savings | through study completion (one year) | incremental cost saving per one immobilization avoided |
| Paramedic Hospital Time | through 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 Hospital | At time of initial injury | Time from paramedic arrival at patient side to ED discharge or admission to hospital |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 3,646 |
Baseline characteristics
| Characteristic | Canadian C-Spine Rule | Total | Control Phase (Usual Care) |
|---|---|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 21.9 | 47.2 years STANDARD_DEVIATION 21 | 48.0 years STANDARD_DEVIATION 21.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 1901 participants | 3646 participants | 1745 participants |
| Sex: Female, Male Female | 998 Participants | 1874 Participants | 876 Participants |
| Sex: Female, Male Male | 903 Participants | 1772 Participants | 869 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,745 | 0 / 1,898 |
| other Total, other adverse events | 0 / 1,745 | 0 / 1,898 |
| serious Total, serious adverse events | 0 / 1,745 | 0 / 1,898 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Phase (Usual Care) | Proportion of Patients Feeling Uncomfortable | 883 Participants |
| Canadian C-Spine Rule | Proportion of Patients Feeling Uncomfortable | 654 Participants |
Proportion of Patients Transported With Spinal Immobilization
Time frame: Through study completion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Phase (Usual Care) | Proportion of Patients Transported With Spinal Immobilization | 1334 Participants |
| Canadian C-Spine Rule | Proportion of Patients Transported With Spinal Immobilization | 813 Participants |
Cost Savings
incremental cost saving per one immobilization avoided
Time frame: through study completion (one year)
Frequency of Cervical Spine Diagnostic Imaging
at initial visit or within 30 days of initial visit
Time frame: within 30 days of initial injury
Number of Missed Cervical Spine Injuries
Time frame: through study completion (one year)
Number of Skin Pressure Injuries
Time frame: through study completion (one year)
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
Paramedic Hospital Time
from arrival at emergency department to transfer of care to emergency department staff
Time frame: through study completion (one year)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Phase (Usual Care) | Proportion of Patients With a Pain Score </= 5/10 | 866 Participants |
| Canadian C-Spine Rule | Proportion of Patients With a Pain Score </= 5/10 | 736 Participants |
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
Subsequent Clinic or Family Physician Visits
within 30 days of initial visit
Time frame: within 30 days of initial injury
Subsequent Emergency Department Visits or Hospital Admissions
within 30 days of initial visit
Time frame: through study completion (one year)
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