Fracture of Cervical Spine
Conditions
Keywords
cervical-spine injuries, cervical-spine fractures, spinal cord injury, neck injury, Canadian C-Spine Rule, paramedics, emergency medical services
Brief summary
The goal of this cohort study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients with the Canadian C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization. The specific objectives of the study are to determine safety, determine the clinical impact and evaluate performance.
Interventions
PROCEDURECanadian C-Spine Rule
Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department.
Sponsors
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* consecutive alert, stable adults evaluated by the paramedics with potential c-spine injury after sustaining acute blunt trauma. Patient eligibility will be determined at the time of paramedic arrival at the scene based on the following criteria: * Potential c-spine injury after sustaining acute blunt trauma will include patients with either: * neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior aspect of the neck), * no neck pain but some visible injury above the clavicles, and/or * neither neck pain nor visible injury, but significant mechanism of injury as determined by the paramedic at the scene. * Alert is defined as a Glasgow Coma Scale score of 15 (converses, fully oriented, and follows commands). * Stable refers to normal vital signs(systolic blood pressure 90 mm Hg or greater and respiratory rate between 10 and 24 breaths per minute). * Acute refers to injury within the past 4 hours.
Exclusion criteria
* Patients under the age of 16 years, * Patients with penetrating trauma from stabbing or gunshot wound, * Patients with acute paralysis (paraplegia, quadriplegia), * Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery), or * Patients referred from another hospital and transported between facilities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | within 30 days of enrollment | Measures of safety will include: 1. number of missed cervical spine injuries 2. number of serious adverse outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance Rate | Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit | Proportion of eligible low-risk patients transported without immobilization |
| Performance of the Canadian C-Spine Rule | Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment. | Measurements of the performance of the rule will include: 1. rule accuracy 2. paramedic accuracy of interpretation 3. paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule |
| Scene Time | immediately following evaluation | Time spent at scene (difference between Paramedic scene departure and arrival at patient side) |
| Average Contact Time | immediately following evaluation | Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eligible Low-risk Trauma Patients Paramedics will use the Canadian C-Spine Rule to evaluate low-risk trauma patients meeting the study inclusion criteria in order to determine the need for spinal immobilization for transport to the hospital.
Canadian C-Spine Rule: Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department. | 4,034 |
| Total | 4,034 |
Baseline characteristics
| Characteristic | Eligible Low-risk Trauma Patients |
|---|---|
| Age, Continuous | 43 years |
| Region of Enrollment Canada | 4034 participants |
| Sex: Female, Male Female | 2150 Participants |
| Sex: Female, Male Male | 1884 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 4,034 |
| serious Total, serious adverse events | 0 / 4,034 |
Outcome results
Primary
Adverse Events
Measures of safety will include: 1. number of missed cervical spine injuries 2. number of serious adverse outcomes
Time frame: within 30 days of enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Low-risk Trauma Patients | Adverse Events | 1 Adverse event |
Secondary
Average Contact Time
Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)
Time frame: immediately following evaluation
Population: In order to be included in this analysis, and to have Contact Time calculated, both the paramedic arrival time and transfer of care time were required. Any case missing this information could not be included in the calculation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Eligible Low-risk Trauma Patients | Average Contact Time | 55 minutes |
Secondary
Clearance Rate
Proportion of eligible low-risk patients transported without immobilization
Time frame: Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Low-risk Trauma Patients | Clearance Rate | 2569 Participants |
Secondary
Performance of the Canadian C-Spine Rule
Measurements of the performance of the rule will include: 1. rule accuracy 2. paramedic accuracy of interpretation 3. paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule
Time frame: Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Low-risk Trauma Patients | Performance of the Canadian C-Spine Rule | 91 percentage of injuries identified |
Secondary
Scene Time
Time spent at scene (difference between Paramedic scene departure and arrival at patient side)
Time frame: immediately following evaluation
Population: In order to be included in this analysis, a valid time for paramedic arrival and paramedic scene departure were required. Any patient refusing transport or missing time information was not included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Eligible Low-risk Trauma Patients | Scene Time | 18 Minutes |