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临床试验/NCT04757805
NCT04757805已完成不适用

Assessment of the Accuracy of the Manual Palpation of Surface Landmarks Versus Ultrasound for Identification of the Correct Intervertebral Space for Spinal Anesthesia in Children Less Than 1 Year of Age

Nationwide Children's Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Intended Interspace

研究概览

简要总结

Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital

排除标准

  • Parents unwilling for their children to undergo spinal anesthesia for surgery.
  • Children with known spinal anomalies including sacral dimple.
  • Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia.
  • Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia.

结局指标

主要结局

Intended Interspace

时间窗: Immediately prior to spinal anesthesia

The vertebral interspace that the anesthesia provider believes that they had marked \& identified by manual palpation

Actual Interspace of Provider's Mark

时间窗: Immediately prior to spinal anesthesia

The actual vertebral interspace that the anesthesia provider marked \& identified, as verified by ultrasound.

次要结局

  • Time to Mark(Immediately prior to spinal anesthesia)
  • Time to Conduct Ultrasound(Immediately prior to spinal anesthesia)
  • Level of Conus Medullaris - Sitting(Immediately prior to spinal anesthesia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giorgio Veneziano

Associate Professor of Clinical Anesthesiology and Pain Medicine

Nationwide Children's Hospital

研究点 (2)

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