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临床试验/NCT01326988
NCT01326988已完成不适用

Feasibility Study of the Use of Real-time Ultrasound Guidance to Administer Spinal Anesthesia

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Rate of successful performance of real-time ultrasound guided spinal needle insertion

研究概览

简要总结

The traditional landmarks to locate the injection site and orientation of the spinal needle for spinal anesthesia are based on palpation of surface bony landmarks. However the actual injection target into the CSF is located at an unknown depth inside the patients 3 dimensional spinal anatomy which can itself vary in its orientation relative to these surface markers.Also bony surface markers may not be palpable in some patients or the patient may have altered spinal alignment. Thus an already blind procedure can become even more misguided involving multiple trial and error needle insertions. On the other hand ultrasound allows visualisation of deep target structures which are impalpable, it allows assessment of spinal alignment and thus directs the orientation of the seeking needle more accurately. Performing US in real-time during needle insertion gives continuous feedback about the correct needle approach path which should reduce the number of blind needle passes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consenting patients of at least 18 years of age undergoing spinal anesthesia for elective lower limb surgery
  • Exclusion Criteria (are as for Spinal anesthesia generally)
  • Patient refusal
  • Sepsis or local infection at the site of injection
  • Hypovolemia
  • Coagulopathy (INR ≥1.5, Platelets < 75X 109 /L, anticoagulant therapy)
  • Indeterminate neurologic disease
  • Increased intracranial pressure
  • Local anesthetic allergy
  • Infection distinct from the site of injection
  • Unknown duration of surgery

排除标准

  • 未提供

结局指标

主要结局

Rate of successful performance of real-time ultrasound guided spinal needle insertion

时间窗: Assessed at time of spinal anesthetic injection (baseline)

Number of ventral passes of the spinal needle into the patient

时间窗: Assessed at time of spinal anesthetic injection (baseline)

次要结局

  • Time for the procedure from first needle contact to the skin to injection of the medication into the spinal canal(Assessed at time of spinal anesthetic injection (baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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