Ultrasound Guided Diagnostic Lumbar Puncture in Neurology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Success rate of obtaining CSF within 3 attempts
研究概览
简要总结
Subjects who are having a lumbar puncture as part of their clinical care will be randomized to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture. The primary objective of study is to compare the success rate of obtaining CSF using Ultrasound guided technique against the Traditional Landmark based approach. Secondary objectives are to evaluate factors influencing the success or failure, patient tolerance, and a safety assessment.
详细描述
Seventy-two subjects will be randomized into either a traditional landmark-based lumbar puncture or an ultrasound-guided lumbar puncture for obtaining CSF. This study will be conducted in the Neurology clinic. For subjects in the traditional group, the site of needle entry will be determined through palpation of the spine. For subjects in the ultrasound group, site entry will be done using ultrasound guidance. Success and failure of these techniques will be compared along with secondary outcome measures aimed at assessing the safety and efficacy of each of these techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for LP through Neurology's LP clinic
- •18 years of age or older
- •Able to understand the description of procedure and provide informed consent
排除标准
- •Any contraindications to doing a standard lumbar puncture; which typically includes risk of bleeding from effects of anticoagulants or bleeding disorders or an infection at the potential site of entry in the back. This includes subjects with spinal cord stimulators.
结局指标
主要结局
Success rate of obtaining CSF within 3 attempts
时间窗: During the baseline visit, approximately 1 hour
The success of the procedure is defined as the ability to obtain CSF within 3 attempts via Landmark based LP vs Ultrasound guided LP
次要结局
- Number of attempts to obtain CSF(Immediately following consent, during baseline visit)
- Incidence of traumatic tap(Time taken to run analysis of CSF RBC count, approximately within 1 day)
- Pain after the procedure(Immediately post-procedure, approximately 5 minutes)
- Occurrence of post LP headache(Phone call within 72 hours of procedure)
- Time to completion of LP, in minutes(Immediately following consent, during baseline visit, approximately 1 hour)