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临床试验/NCT01570491
NCT01570491已完成不适用

Cardiothoracic Anesthesia and Critical Care Patient Registry

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年3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
38
试验地点
2
主要终点
Number of Attempts

研究概览

简要总结

Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.

详细描述

Patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique.

A block randomization scheme with random block sizes ranging from 2-8 patients will be used. The outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. The post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block.

No sample size estimation methodology currently exists for the right-censored count data models. We expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total.

The analysis will be conducted by a statistician who will be blinded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients aged 55 or older
  • BMI more than 40
  • Exclusion criterion:
  • 1 Patients who have undergone previous Spine Surgery

排除标准

  • 未提供

结局指标

主要结局

Number of Attempts

时间窗: 10-15 minutes before the surgery

Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery

次要结局

  • Time to Perform Block (Second)(as measured in seconds after needle insertion, surgical date)
  • Difficulty of Block Insertion(10-15 minutes before the surgery)
  • Patient Satisfaction(after insert the block but before the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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