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临床试验/NCT04329026
NCT04329026已完成不适用

The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2020年4月7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
116
试验地点
1
主要终点
First attempt success rate

研究概览

简要总结

The primary objective of the study is to evaluate the effect of smart glasses (Head-mounted display Moverio BT-300 (Epson Inc., USA)) on the first-attempt success rate of radial artery cannulation in pediatric patients. This study hypothesizes that the use of smart glasses improves the hand-eye coordination and the first-attempt success rate of radial artery cannulation. This is a single-center, randomized, placebo-controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the radial arterial cannulation in pediatric patients undergoing general anesthesia.

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
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • General anesthesia
  • Arterial cannulation for hemodynamic monitoring, multiple blood sample

排除标准

  • Unstable vital sign, significant arrhythmia or hypotension, Shock
  • High risk of peripheral ischemia
  • Skin disease, infection, hematoma, recent cannulation at radial artery

结局指标

主要结局

First attempt success rate

时间窗: During radial artery cannulation (up to 1 hour)

Success at the first skin puncture

次要结局

  • Malfunction of radial artery catheter(After radial artery cannulation assessed during anesthesia (up to 24 hour))
  • Complication rate(After radial artery cannulation assessed up to PACU, PICU stay (up to 24 hour))
  • Overall attempt(During radial artery cannulation (up to 1 hour))
  • Operator's satisfaction(During radial artery cannulation (up to 1 hour))
  • Size of radial artery(Before and after subcutaneous injection of drugs (up to 1 hour))
  • depth of radial artery(During radial artery cannulation (up to 1 hour))
  • Overall Procedure time(During radial artery cannulation (up to 1 hour))
  • Overall success rate(During radial artery cannulation (up to 1 hour))

研究者

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

Jin-Tae Kim

Professor

Seoul National University Hospital

研究点 (1)

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