Evaluation of the safety of C-spine clearance by paramedics: design and methodology

The goal of this study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients using a validated clinical decision rule, the Canadian C-Spine Rule, in order to determine the need for immobilization during transport to the emergency department.This cohort study will be conducted in Ottawa, Canada with one emergency medical service. Paramedics with this service participated in an earlier validation study of the Canadian C-Spine Rule. Three thousand consecutive, alert, stable adult trauma patients with a potential c-spine injury will be enrolled in the study and evaluated using the Canadian C-Spine Rule to determine the need for immobilization. The outcomes that will be assessed include measures of safety (numbers of missed fractures and serious adverse outcomes), measures of clinical impact (proportion of patients transported without immobilization, key time intervals) and performance of the Rule.Approximately 40% of all very low-risk trauma patients could be transported safely, without c-spine immobilization, if paramedics were empowered to make clinical decisions using the Canadian C-Spine Rule. This safety study is an essential step before allowing all paramedics across Canada to selectively immobilize trauma victims before transport. Once safety and potential impact are established, we intend to implement a multi-centre study to study actual impact.ClinicalTrials.gov NCT01188447Neck injuries are a common problem among blunt trauma victims with more than 8,000,000 cases being seen annually in U.S. and Canadian Emergency Departments (ED) [1]. 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 [2-4]. 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 [1]. The prevale