Fracture of Cervical Spine Clinical Trial
Official title:
Evaluation of the Safety of C-Spine Clearance by Emergency Department Triage Nurses (Phase IV)
Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases being seen annually in U.S. and Canadian EDs. While the majority of these cases represent soft tissue injuries, 30,000 patients suffer cervical spine fractures or dislocations and approximately 10,000 suffer spinal cord injury. There are no readily available national Canadian data on ED visits such as those provided by the U.S. National Hospital Ambulatory Medical Care Survey. The prevalence of potential neck injury can, however, be reasonably estimated for Canadian EDs. Extrapolation, on a population basis, from reliable U.S. figures suggests that 1.3 million potential neck injury patients are seen annually in Canada. Only 0.9% of these patients are found to have cervical spine fractures or dislocations.
Background: Canadian emergency departments (EDs) annually treat 1.3 million patients who
have suffered blunt trauma from falls or motor vehicle collisions and who are at risk for
cervical spine injury. Most such cases are alert and stable adults and less than 1% has a
c-spine fracture. Most trauma victims transported in ambulances are protected by a
backboard, collar, and sandbags and, on arrival at the ED, are sent to high acuity
resuscitation rooms, where they remain fully immobilized for hours until physician
assessment and radiography are complete. This prolonged immobilization is often unnecessary
and adds considerably to patient discomfort and also adds to the burden of our overcrowded
Canadian EDs in an era when they are under unprecedented pressures. These patients use
valuable ED resuscitation room space.
Nurses usually do not evaluate the c-spine of trauma patients but the investigators believe
that they should be able to safely assess alert and stable ambulance patients and "clear"
the c-spine of low-risk cases on arrival at the triage station. Patients could then be much
more rapidly, comfortably, and efficiently managed in other areas of the ED. An expanded
role for nurse decision-making has the potential to improve trauma care efficiency in all
Canadian hospitals. Very little research has been done in this area of nurses' clearing
patient c-spines.
A clinical decision rule is derived from original research and is defined as a decision
making tool that incorporates three or more variables from the history, examination, or
simple tests. This Canadian C-Spine Rule (CCR) is comprised of simple clinical variables and
was designed to allow clinicians to "clear" the c-spine without radiography and to decrease
immobilization times. The investigators also validated the accuracy of the rule when used by
physicians. The investigators have now finished a funded study to validate the accuracy and
reliability of the CCR when used by ED triage nurses at 6 hospitals. The investigators
completed a funded implementation trial at 12 Canadian hospitals to evaluate the impact on
patients of the CCR when used by physicians.
Objectives: The goal of phase IV of the Canadian C-Spine Rule project is to evaluate the
safety and potential impact of an active strategy to empower ED triage nurses to evaluate
and clear the c-spine of very low-risk trauma patients. Specific objectives are to: 1)
Determine safety by screening for: a) Missed fractures and b) Serious adverse outcomes; 2)
Determine clinical impact by measuring: a) C-spine clearance rates by nurses, b) Length of
time until c-spine clearance; 3) Evaluate performance of the Canadian C-Spine Rule for: a)
Accuracy, b) Nurse accuracy in interpretation, and c) Nurse comfort and compliance.
Methods: The investigators propose a cohort study which evaluates outcomes during a 12-month
period at 5 hospital EDs, including 3 community and 2 teaching hospital sites. Enrolled will
be consecutive, alert and stable adult trauma patients presenting to the ED with neck pain
or with c-spine immobilization on an ambulance stretcher. Participating will be ED triage
nurses who previously underwent a structured educational strategy to learn the CCR and who
successfully participated in the 24-month phase IIb validation study at the same sites.
These nurses will be empowered by medical directive to "clear" the c-spine of patients
according to the CCR, thus allowing them to remove c-spine immobilization and to triage
patients to a less acute area of the ED. These outcomes will be assessed: 1) Measures of
safety: a) Number of missed fractures, b) Number of serious adverse outcomes; 2) Measures of
clinical impact: a) C-spine clearance rates by nurses, b) Length of stay in ED, and c)
Patient satisfaction; 3) Performance of the Canadian C-Spine Rule: a) Accuracy, b) Nurse
accuracy of interpretation, and c) Nurse comfort. The investigators estimate a sample size
of 1,500 patients will be accrued.
Importance: This evaluation study (phase IV) is an essential step in the process of
developing a new clinical decision rule / guideline for nurses to clear the c-spine. Once
the investigators have established safety and potential impact in phase IV, the
investigators can move to the final step (phase V), a multicenter implementation across
Canada to study actual impact. The investigators believe that teaching ED triage nurses to
clear the c-spine of very low-risk trauma patients has the potential to significantly
improve the efficiency and comfort of patient care in our busy Canadian EDs. Ultimately, the
investigators expect the results of this study to be used by ED triage nurses throughout
Canada.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01188447 -
Evaluation of the Safety of C-Spine Clearance by Paramedics
|
N/A |