Evaluation of the Safety of C-Spine Clearance by Paramedics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,034
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Canadian C-Spine Rule (Procedure)
结局指标
主要结局
Adverse Events
时间窗: within 30 days of enrollment
Measures of safety will include: 1. number of missed cervical spine injuries 2. number of serious adverse outcomes
次要结局
- Clearance Rate(Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit)
- 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.)
- Scene Time(immediately following evaluation)
- Average Contact Time(immediately following evaluation)