NCT03167190终止不适用
Ultrasound-localized Landmark Identification in Hospitalized Patients Requiring Lumbar Puncture: Implications for Safety, Quality, and Procedural Success
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Mean Procedural Duration
研究概览
简要总结
Although the lumbar puncture is a common procedure and has been performed without ultrasound for decades, other research studies suggest that there may be some benefits to using ultrasound. This study intends to see whether by using ultrasound there is increased success rate, decreased need for additional procedures, and less discomfort during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who registered for an emergency or inpatient encounter between 5/22/2017 and 5/08/2018
- •Males or females 18 years of age or older
- •Patients who have been identified as requiring a lumbar puncture for any therapeutic or diagnostic or therapeutic indication, as decided by the neurology staff physicians, residents, or advanced practice providers.
排除标准
- •Patients who are not capable of providing consent for participation in research and do not have an authorized relative or power of attorney to consent in their stead.
- •Patients who require lumbar puncture in an emergency, time dependent fashion and in whom a possible delay could conceivable have a negative clinical impact.
- •Patients with known abnormal lumbar spinal anatomy or prior extensive surgical fusion such that fluoroscopic or CT guidance is determined to be more clinically appropriate by the treating physicians.
- •BMI greater than 60
- •Absolute contraindication to lumbar puncture such as uncorrected coagulopathy
结局指标
主要结局
Mean Procedural Duration
时间窗: Approximately 1 hour
This is defined by number of minutes from initiating of patient positioning (prior to evaluation of the anatomical landmarks) to first flow of cerebrospinal fluid (CSF).
次要结局
- Number of Procedures Considered to be Failures(Approximately 1 hour)
- Patient reported discomfort(Approximately 1 day)
- Hospital Length of Stay(Approximately 1 month)
- Procedurist reported ease of the procedure(Approximately 1 day)
- Number of Fluoroscopically Guided or CT Guided Lumbar Punctures(Approximately 7 days)
- Total number of unique skin punctures(Approximately 1 day)
- Number of red blood cells in collected CSF(Approximately 1 day)
研究者
Michael P Boniface
M.D., Principal Investigator
Mayo Clinic
研究点 (2)
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