跳至主要内容
临床试验/NCT00980070
NCT00980070Unknown1 期

The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

University of Nebraska1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年10月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
30
试验地点
1
主要终点
To evaluate the safety of the lumbar puncture restraint board

研究概览

简要总结

This is a pilot study to evaluate a restraint device for lumbar punctures. Designed to help improve the restraint techniques for lumbar puncture, the restraint device will be compared to the current standard of manual physical restraint in neonatal and pediatric patients (age 1 day to 90 days of life). The investigators will study 30 subjects, with 20 randomized for the experimental device and 10 randomized for the "control" group, which is current standard of care. The investigators' primary outcomes will include time of procedure, red blood cells in the cerebrospinal fluid as well as physician satisfaction. Subjects will be eligible if they are 1-90 days of life, and their treating physician believes lumbar puncture is indicated. There is no follow-up once the lumbar puncture has been completed and the data has been obtained.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
1 Day 至 90 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Age 1 to 90 days of life
  • Indication for lumbar puncture procedure as determined by the treating physician
  • Informed Consent from the subject's legal guardian indicating their acceptance of a lumbar puncture for the work-up of sepsis
  • Informed consent to enrolled in said protocol

排除标准

  • No indication for lumbar puncture procedure as determined by treating physician

研究组 & 干预措施

Control

Active Comparator

institutional standard of care

干预措施: Standard of Care (Other)

Positioning Device

Experimental

use of positioning device

干预措施: Pediatric Restraint for Lumbar Puncture (Device)

Positioning Device

Experimental

use of positioning device

干预措施: Lumbar Puncture Device (Device)

结局指标

主要结局

To evaluate the safety of the lumbar puncture restraint board

时间窗: one time use

次要结局

  • To evaluate the effect of the restraint board on the quality of the procedure (time of procedure, quality of specimen obtained, physician impression)(One time use)

研究者

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

Angela Boettner

coordinator

University of Nebraska

研究点 (1)

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