跳至主要内容
临床试验/NCT05009173
NCT05009173招募中不适用

LiPSTICk Trial-Lumbar Puncture Stylet Technique in Children; A Randomized-controlled Study

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 395 人开始时间: 2020年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
395
试验地点
2
主要终点
First-time lumbar puncture success rate

研究概览

简要总结

Lumbar puncture (LP) is a procedure performed frequently among children in the emergency department (ED). Although it has been performed for decades, and for distinct indications, the technique itself can often lead to traumatic results, which can complicate its interpretation and lead to over-treatments and hospitalizations. Several factors have been suggested to improve the success rate of LPs. Among them, the stylet-out (SO), also known as the early stylet removal technique, has been suggested but not properly studied.

The aim of this study is to evaluate whether the stylet-out technique can reduce the probability of failure or traumatic lumbar puncture procedures in a pediatric population presenting to the emergency department as compared to the standard stylet-in (SI) approach.

To achieve this goal, the investigator will conduct a randomized controlled trial comparing the SO versus SI techniques in a tertiary care, pediatric, university-affiliated emergency. All children younger than 18 years of age requiring a LP as part of their ED workup will be eligible and randomized to either the standard SI or SO group. The primary outcome will be the first-attempt LP success rate as defined by the minimum amount of cerebrospinal fluid (CSF) necessary to perform a leukocyte count and bacterial/viral CSF cultures, according to each laboratory with red blood cell count < 1000/mm3. Secondary outcomes will include the following: overall LP success rate (i.e. despite number of attempts), proportion of traumatic LP, number of LP attempts, number of changes in providers performing the LP, proportion of traumatic LP, total time to procedure, mean difference in pain scores and satisfaction rates in both groups.

The hypothesis is that the use of the Stylet Out approach will reduce the number of failed and traumatic LP in the pediatric population presenting to the ED as compared to the standard SI approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
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

  • All patients younger than 18 years of age (no minimal age)
  • All patients who require a diagnostic lumbar puncture as part of their emergency department workup

排除标准

  • Patients with lumbar puncture contraindications
  • Parents/patients unable to give consent
  • Patients who have had a traumatic of failed lumbar puncture prior to the emergency department transfer

结局指标

主要结局

First-time lumbar puncture success rate

时间窗: 1 hour after procedure

Defined as the minimum amount of CSF necessary to perform a leukocyte count and a CSF bacterial/viral culture, according to the hospital laboratory, with a red blood cell count \<1,000/mm3

次要结局

  • Number of lumbar puncture attempts in total(immediately after procedure)
  • Proportion of final traumatic lumbar puncture(1 hour after procedure)
  • Length of procedure(immediately after procedure)
  • Lumbar puncture success rate despite the number of attempts(1 hour after procedure)
  • Number of changes in provider performing the lumbar puncture(immediately after procedure)
  • Mean difference in Evendol pain scores and NRS-11 scores(during procedure)
  • Satisfaction with procedure(immediately after procedure)

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

Ariane Boutin MD, MSc FRCPC

Principal investigator

St. Justine's Hospital

研究点 (2)

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