跳至主要内容
临床试验/NCT05409807
NCT05409807招募中不适用

Comparison of Classical Ultrasound Guided Method and Combined Wearable Display Technology Method With Ultrasound in Interscalene Nerve Block Applied in Shoulder Surgery

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
First attempt success rate

研究概览

简要总结

This study hypothesizes that the use of smart glasses (Head-mounted display Vufine, model VUF-110, Vufine Inc., China)) improves the hand-eye coordination and the first-attempt success rate of ultrasound guided interscalene nerve block. This is a single-center, randomized, controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the interscalene block.

详细描述

Peripheral nerve blocks, which help patients to recover early after surgery, are performed safely and successfully under ultrasound guidance. Ultrasound-guided peripheral nerve blocks provide sufficient anesthesia for the operation alone or can be applied in combination with general anesthesia and provide postoperative analgesia.

Investigators encounter new developments in health technologies almost every day. With the development of smart technologies and the spread of wearable devices, their use in the field of health is increasing day by day.

Hand-eye coordination is an important skill, especially in the use of ultrasound. The inserted needle should be followed during the procedure in the appropriate area and safely delivered to the desired area.

Patients will be divided into either the study group or the control group. Interscalene nerve block will be performed with preoperative sedation, ultrasound guidance and nerve stimulator.

Interscalene nerve block will be applied to the patients in the study group by using the smart glasses screen, and to the patients in the control group with the conventional ultrasound screen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are planned to undergo surgery under general anesthesia
  • Patients scheduled for postoperative analgesia after shoulder surgery

排除标准

  • Local anesthetic allergy
  • Skin disease, infection, hematoma
  • Chronic obstructive pulmonary disease
  • Hepatic, renal, cardiac failures
  • Pregnancy
  • Uncooperative patient

结局指标

主要结局

First attempt success rate

时间窗: During peripheral nerve block procedure. Not to exceed 20 minutes

Ultrasound visualization and neurostimulator confirmation of the nerve plexus sheath being reached

次要结局

  • Overall attempt(During peripheral nerve block procedure. Not to exceed 20 minutes)
  • Ultrasound image time(During peripheral nerve block procedure. Not to exceed 20 minutes)
  • Nerve block time(During peripheral nerve block procedure. Not to exceed 20 minutes)
  • Overall success rate(During peripheral nerve block procedure. Up to 1 day)
  • Operator's satisfaction(During peripheral nerve block procedure. Not to exceed 20 minutes)
  • Complication rate(Through study completion, an average of 2 week)

研究者

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

Ilker Ital

Assistan Professor Doctor

Abant Izzet Baysal University

研究点 (2)

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