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临床试验/NCT02032420
NCT02032420已完成不适用

A Double Blinded Randomized Controlled Trial on the Effects of Four Sequential Maneuvers on Ultrasound Guided Nerve Block Performance

University of New Mexico2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2012年10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
35
试验地点
2
主要终点
Task Completion Time

研究概览

简要总结

Volunteers will watch a training video demonstrating how to place a needle in the correct position while keeping it visible. Later the volunteers will be placed in front of a set up identical to the video, and asked to demonstrate how to direct an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade phantom a total of three times.

详细描述

After watching the training video, each volunteer will be placed in front of a set up identical to the video seen. Adjacent to this set up, a single fellowship trained regional anesthesiologist known as the assessor is situated with a screen that allows real time viewing of the ultrasound screen seen by the volunteer. The assessor is blinded to the assignment of the volunteer. Also, the assessor does not have any visualization of the volunteer. This prevents visualizing hand or body movement that may cause a bias. The same assessor is used for the whole study to provide consistent assessment of the task.

The task involves the volunteer directing an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade phantom. The targets simulate the nerve roots commonly found in the interscalene block. Thus, they are arranged diagonally to simulate the nerve root position commonly seen. Also, they are arranged on a tilt relative to the flat surface of the phantom to simulate the direction the nerve travels. This is important as the tilt of the target requires the volunteer to tilt the probe so that their incidental ultrasound wave is perpendicular to the target for the brightest reflection to occur. This phenomenon is known as anisotropy. This increases the realism of the task that cannot be imitated by commercially available phantoms.

There are 3 goals that the volunteer must fulfill in performing their task. Firstly, they must direct the needle to the 12 o'clock position of the 3 targets. Secondly, they must achieve maximal ultrasound image brightness of the 3 targets at all times. Thirdly, the entire needle must be visualized at all times.

If the needle is not in the correct position, the assessor will verbally inform the volunteer to redirect it to the correct position. If the target images are not at their brightest, the assessor will verbally inform the volunteer not to manipulate the needle towards the target until the targets are at their brightest. Clinically, this functions to prevent the needle being inserted inside the nerve as the targets are not clearly seen. Thirdly, if the needle is visualized entirely, the volunteer will be told to stop manipulating the needle towards the target until the needle is fully visualized by manipulating the probe. A timer records the cumulative time the needle is not in full visualization. Clinically, this functions to prevent the needle being inserted into a nerve or structure that it should not.

After all 3 targets have been completed, the volunteer repeats the task a total of 3 times.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Healthy volunteers
  • Right handed
  • Aged 18 to 55

排除标准

  • Any person who has prior knowledge about ultrasound imaging or regional anesthesia
  • Any person who has prior experience with laparoscopy or biopsy
  • Any person who has problems with depth of field or simple hand eye co-ordination task

结局指标

主要结局

Task Completion Time

时间窗: Immediately after training

Median time taken to complete 3 iterations of the assigned task, across participants within a study arm

次要结局

  • Needle-not-seen Time(During attempt)
  • Performer Fatigue(During task)

研究者

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

Timothy R Petersen

Research Information Specialist

University of New Mexico

研究点 (2)

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