NCT01278511撤回不适用
A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- KU Leuven
- 试验地点
- 2
- 主要终点
- Missed cervical spine injuries and fractures
研究概览
简要总结
This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
- •Alert: GCS ≥ 14
- •systolic blood pressure ≥ 90 mmHg
- •respiratory frequency 12 - 20 / min
- •adult ≥ 18 years old
- •Acute: ≤ 4
- •Possible injury to the cervical spine:
- •posterior neck pain following any mechanism
- •no neck pain but visible injury above the clavicles
- •no neck pain or visible injury above the clavicles but a mechanism that indicates a cervical spine injury
排除标准
- •Acute paralysis (quadriplegia, paraplegia)
- •Penetrating trauma to the neck
- •Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery)
- •Pregnancy
结局指标
主要结局
Missed cervical spine injuries and fractures
时间窗: At the first visit to the emergency department until 30 days after inclusion
次要结局
- Level of comfort(Analyzed at the end of the pilot study in april 2011)
- Performance of the Canadian c-spine rule(Analyzed at the end of the pilot study in april 2011)
研究者
Pieter Jan Van Asbroeck
Dr. Pieter Jan Van Asbroeck
KU Leuven
研究点 (2)
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