The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial
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
- 否
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
研究组 & 干预措施
Smart Glasses
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
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
- 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
Jin-Tae Kim
Professor
Seoul National University Hospital