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临床试验/NCT05030649
NCT05030649已完成不适用

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

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
122
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 by less experienced trainees. 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 by less experienced trainees.

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
Single (Participant)

入排标准

年龄范围
— 至 7 Years(Child)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Smart Glasses

Experimental

The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.

干预措施: Smart glasses (Device)

Control

Active Comparator

The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.

干预措施: Control (Device)

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

  • Complication rate(After radial artery cannulation assessed up to PACU, PICU stay (up to 24 hour))
  • Operator's experience(During radial artery cannulation (up to 1 hour))
  • Operator's satisfaction(During radial artery cannulation (up to 1 hour))
  • Malfunction of radial artery catheter(After radial artery cannulation assessed during anesthesia (up to 24 hour))
  • Overall Procedure time(During radial artery cannulation (up to 1 hour))
  • Ultrasound image time(During radial artery cannulation (up to 1 hour))
  • Arterial cannulation time(During radial artery cannulation (up to 1 hour))
  • Overall success rate(During radial artery cannulation (up to 1 hour))
  • Size of radial artery(During radial artery cannulation (up to 1 hour))
  • depth of radial artery(During radial artery cannulation (up to 1 hour))
  • Overall attempt(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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