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临床试验/NCT03099642
NCT03099642已完成不适用

Emergency Physician Performed Ultrasound-Assisted Lumbar Puncture in a Pediatric Population: A Randomized Controlled Trial

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2017年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
166
试验地点
2
主要终点
First-tie success

研究概览

简要总结

The aim of this study is to determine if emergency physician performed ultrasound-assisted lumbar puncture improves first-time success rates in a pediatric population. This will be done by comparison with current landmark-based approach to the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient less than 19 years of age
  • Requiring a lumbar puncture as part of their work-up, as determined by the treating pediatric emergency physician.

排除标准

  • • Patients with known spine or spinal cord abnormalities
  • Patients with ventricular shunts
  • Patients deemed too unstable to have procedure performed
  • Patients at risk for significant bleeding (coagulopathy, thrombocytopenia, etc)
  • Parents unable to give consent or patients unable to assent for an acute reason

研究组 & 干预措施

Ultrasound assisted lumbar puncture

Experimental

The intervention of interest will be the ultrasound-assisted lumbar puncture (UALP). To do this, the treating physician will perform a bedside ultrasound of the spine to identify and mark the level of the conus medullaris and preferred puncture site prior to LP

干预措施: ultrasound-assisted lumbar puncture (Radiation)

Standard lumbar puncture

No Intervention

The control group will have a standard landmark-based lumbar puncture

结局指标

主要结局

First-tie success

时间窗: 15 minutes

First-time lumbar puncture success rate is defined by the presence of at least 0.5 mL of cerebrospinal fluid with red blood cell count \< 1,000/mm3.

次要结局

  • Total lumbar puncture success rate(15 minutes)
  • Complication(30 minutes)
  • Time of procedure(30 minutes)
  • Change in performer(15 minutes)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jocelyn Gravel

MD, MSc

St. Justine's Hospital

研究点 (2)

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