跳至主要内容
临床试验/NCT02918149
NCT02918149已完成不适用

A Randomized Controlled Trial of Ultrasound-Assisted Versus Traditional Landmark Lumbar Puncture in the Neonatal and Infant Population

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2016年9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
91
试验地点
1
主要终点
Proportion of successful first attempt LPs

研究概览

简要总结

Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as a method to improve success but it is not known if it helps. This study is designed to see if ultrasound improves the success rate.

详细描述

Obtaining cerebrospinal fluid (CSF) through a lumbar puncture (LP) is an essential procedure in the neonatal/infant intensive care unit (N/IICU) for establishing diagnosis and determining treatment. The traditional technique for performing an LP involves palpation of anatomic landmarks followed by a "blind" stick of the appropriate inter-spinous process space. This technique has a failure rate (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) of 15-50%.

Bedside ultrasonography possesses the ability to visualize the anatomic landmarks, including the subarachnoid space. In the adult literature, ultrasound has been shown to reduce the LP failure rate. Its utility has also been shown to significantly improve success rates and accuracy in epidural needle placement in neonates and children undergoing regional anesthesia. Increasing the proportion of successful LPs in the N/IICU could significantly reduce patient/family discomfort, sedation exposure, off unit travel, additional interventional procedures and antibiotic use. However, research on the utility of bedside ultrasound assisted LPs by clinicians working in an N/IICU is lacking.

This is a prospective randomized controlled trial. Eligible subjects will be randomized to undergo LP (performed as part of their standard of care) with ultrasound assisted method or traditional landmark method.

Primary Objective:

-To determine if bedside ultrasound-assisted LP, performed by N/IICU clinicians on neonates and infants aged ≤6 months, increases the proportion of successful first attempt non-traumatic LPs when compared to a traditional landmark palpation technique.

研究设计

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

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates and infants aged ≤6 months
  • Clinical indication for a lumbar puncture (LP), as determined by the clinical team
  • Availability of study personnel to perform bedside ultrasound

排除标准

  • Known spinal cord abnormality (for e.g., tethered cord, spina bifida)
  • Presence of skin and soft tissue infection at insertion site
  • Recent failed LP traumatic LP attempts within the preceding 48 hours
  • Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days
  • Clinically unstable patient, as determined by the clinical team
  • Eligible patients on the resident care team

研究组 & 干预措施

Palpation Landmark Technique LP

Other

Traditional landmark palpation technique will be used to perform LP

干预措施: Palpation Landmark Technique (Other)

Ultrasound-Assisted Technique LP

Experimental

Bedside ultrasonography exam will be used for identification of anatomic landmarks before performing LP

干预措施: Ultrasound-Assisted Technique LP (Device)

结局指标

主要结局

Proportion of successful first attempt LPs

时间窗: Up to 30 minutes

The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group.

Proportion of Successful First Attempt LPs

时间窗: Up to 30 minutes

The proportion of successful first attempt LPs (defined as obtainment of CSF and non-traumatic LP) for patients in the ultrasound-assisted group compared to the traditional landmark palpation group.

次要结局

  • Proportion of overall success of LPs within 2 attempts(Up to 30 minutes)
  • Difference in length of antibiotic exposure(Length of Hospitalization (approximately 1 month))
  • Proportion of Overall Success of LPs Within 2 Attempts(Up to 30 minutes)
  • Difference in Length of Antibiotic Exposure(Length of Hospitalization (approximately 1 month))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验