跳至主要内容
临床试验/NCT06584864
NCT06584864招募中不适用

Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children - Open-label Randomized Trial

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年3月1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
120
试验地点
2
主要终点
Obtaining cerebrospinal fluid after the first attempt at lumbar puncture

研究概览

简要总结

The aim of the study is to assess the influence of ultrasound examination of the lumbar spinal canal on the effectiveness of lumbar puncture. An open-label, randomized interventional study.

详细描述

Lumbar puncture is a common procedure performed in pediatric departments. The most common purpose of the examination in the pediatric patient population is to exclude infectious diseases of the central nervous system: meningitis and encephalitis. Risk factors for traumatic or unsuccessful puncture include, among others: patient age less than 3 months, difficulty in identifying anatomical structures by palpation, lack of local anesthesia, lack of experience of the person performing the procedure, and patient movement during puncture. The use of spinal canal ultrasonography before performing lumbar puncture brings promising benefits. Ultrasound imaging can be helpful in visualizing key anatomical structures within the spinal canal and increasing the certainty of correct performance of the procedure, especially in inexperienced physicians.

The study objective is to assess the effect of ultrasound imaging of the lumbar spinal canal on the effectiveness of lumbar puncture.

We plan to include every child <18 years old with an indication for lumbar puncture to the one of the two groups (ultrasound group and standard group)

Before the procedure, doctors performing the lumbar puncture in both groups will complete a questionnaire regarding their previous experience In the USG group, before performing the lumbar puncture, one of the two researchers will perform a bedside ultrasound examination of the lumbar spinal canal.

The ultrasound examination will be performed using a Lumify linear probe (frequency range 4-12 MHz). In the longitudinal projection, the doctor will assess the sites of the spinal cord endings by marking them with a sterile marker - a horizontal line on the patient's back. In the same projection, the doctor will designate a safe and optimal site (the greatest width of the dural sac) for performing a lumbar puncture by marking it with a sterile marker. Additionally, in the longitudinal projection, the researcher will measure the depth from the skin surface to the dura mater. Then, in the transverse projection, the doctor will confirm the absence of the spinal cord at the planned puncture site and the optimal amount of cerebrospinal fluid in the selected space. This information will be passed on to the operator, who will ultimately decide on the location of the lumbar puncture.

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

盲法说明

open-label study

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

  • children <18 years of age
  • patients who are scheduled to undergo lumbar puncture
  • consent of legal guardian

排除标准

  • infection of skin and tissues in the area of planned puncture
  • developmental defects of the spine and spinal cord
  • lack of consent of legal guardian
  • contraindications to lumbar puncture

结局指标

主要结局

Obtaining cerebrospinal fluid after the first attempt at lumbar puncture

时间窗: 1 day

Obtaining cerebrospinal fluid after the first attempt at lumbar puncture (at least 0.5 ml in volume, with a red blood cell count of \<10,000/mm3).

次要结局

  • obtaining cerebrospinal fluid - < 10,000/mm3 - at any attempt(1 day)
  • obtaining cerebrospinal fluid - > 10,000/mm3 - at any attempt(1 day)
  • total number of puncture attempts to obtain cerebrospinal fluid(1 day)
  • unsuccessful puncture - failure to obtain cerebrospinal fluid(1 day)
  • duration of puncture(1 day)
  • assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the experience of the physician performing the lumbar puncture(1 day)
  • assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the patient's BMI z-score(1 day)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验