Bedside Ultrasound Assisted Pediatric Lumbar Puncture--A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Traumatic lumbar puncture
研究概览
简要总结
This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients
详细描述
Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study
排除标准
- •previous back surgeries
- •parent/ guardian inability to understand informed consent
- •parent/guardian refusal of informed consent.
研究组 & 干预措施
90 days and under--Interventional
Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture
干预措施: Ultrasound assisted lumbar puncture (Procedure)
90 days and under--control
Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach
Over 90 days--Interventional
Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture
干预措施: Ultrasound assisted lumbar puncture (Procedure)
Over 90 days--Control
Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach
结局指标
主要结局
Traumatic lumbar puncture
时间窗: up to 24 hours
RBC\>10,000/ mm3 on spinal fluid analysis
Unsuccessful lumbar puncture
时间窗: average of <1hour
failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet
次要结局
- Hospital length of stay(average of <7days)