跳至主要内容
临床试验/NCT02949869
NCT02949869已完成不适用

Variability of Infant LP Insertion Site Based On Procedural Experience

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2016年11月1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
入组人数
110
试验地点
1
主要终点
Proportion of Trainee & Attending LP Insertion Sites that are the same

研究概览

简要总结

The reported rate of unsuccessful traditional LP in children (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many factors affect LP success including provider experience. CSF is obtained by puncturing the subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and many have hypothesized that the width of this space may predict success. Anecdotally, trainees and those with less experience, tend to perform the LP too low (caudally), where the subarachnoid space tapers, or too laterally (off the midline) resulting in higher failure rates. The investigators seek to determine if planned LP insertion sites vary between training and attendings, and if so, could the decreased success be explained by smaller subarachnoid spaces.

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
— 至 12 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Less than or equal to 12 months of age
  • •Availability of a study sonographer to perform bedside ultrasound

排除标准

  • •Prior history of LP in preceding 72 hours
  • •Known spinal cord abnormality (i.e., tethered cord, spina bifida)
  • •Clinically unstable patients (acuity level 1)

研究组 & 干预措施

Infant Lumbar Punctures

Experimental

Infants will all be assigned to received two sets of skin markings and sonography exam to assess lumbar puncture landmarks and anatomy.

干预措施: Spinal Sonography (Other)

结局指标

主要结局

Proportion of Trainee & Attending LP Insertion Sites that are the same

时间窗: 18 months

Plan to visualize marked spaces with US to delineate if the trainee and attending marked the same or different interspace (we will quanity the proportion of same interspaces marked and for those that are different, we will quantify the proportion above or below the attending marking)

次要结局

  • Subarachnoid Space Area(18 months)
  • Subarachnoid Space Width(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Vieira

MD

Boston Children's Hospital

研究点 (1)

Loading locations...

相似试验