Sonographic Visualization vs Palpation Technique for Infant Lumbar Puncture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts
研究概览
简要总结
The purpose of this study is to determine if performing an ultrasound to identify the space to insert the needle before performing a lumbar puncture will improve success of the procedure and patient safety.
详细描述
The investigators are conducting a single-center, prospective two-arm parallel group randomized clinical trial in an urban pediatric emergency department to determine if performing an ultrasound prior to lumbar puncture procedure improves success of the procedure.
Patients will be block-randomized into two groups to receive procedural interspace selection via 1) standard anatomic palpation technique or 2) visualization with pre-procedural ultrasound (experimental group).
- Standard Anatomic Palpation Technique:
Participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace. As variations on the palpation technique exist, the investigators will provide a standardized educational cognitive aid that clinicians can use for this approach. 2. Pre-Procedural Ultrasound:
Clinicians will first use the standard palpation technique to select an interspace for ultrasound evaluation. A select group of pediatric emergency medicine attendings and fellows who have already trained to a mastery standard with the ultrasound protocol will then conduct the pre-procedural ultrasound. The clinicians performing the lumbar puncture will be provided the following information to conduct 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
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is less than 90 days old.
- •Patient is receiving a lumbar puncture
排除标准
- •Patient is clinically unstable
- •Patient had a previous lumbar puncture in the past 24 hours
- •An outside consultant (not working in ED) is performing the LP
- •Patient has developmental delay or neurological impairment
- •There is no legal guardian present
- •The legal guardians speak neither English nor Spanish
- •There is no ultrasound personnel available to enroll
结局指标
主要结局
Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts
时间窗: Outcome measured on the same day of the procedure
Our primary outcome of the clinical trial is binary, success or failure of lumbar puncture. Success is defined as obtaining a sample of cerebrospinal fluid on the first attempt that has a red blood cell count of \<1000 red blood cells per high-powered field.
次要结局
- Number of Attempts- Per Direct Observation(Outcome measured at the time of the procedure (same day))
研究者
David Kessler
Assistant Professor
Columbia University