The Effectiveness of a Pediatric Lumbar Puncture Restraint Device
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 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
- 否
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
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
Angela Boettner
coordinator
University of Nebraska