The Usefulness of Smart-glasses During Ultrasound-guided Central Venous Catheterization in Pediatric Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1st success rate
研究概览
简要总结
This study is intended to investigate usefulness of smart-glasses for ultrasound-guided central venous catheterization in pediatric patients, by comparing success rate and elapsed time. The hypothesis is that smart-glasses would increase success rate in first trial.
详细描述
After obtaining informed consent from patients' legal guardian, children aged 6 or less undergoing surgery with need for central venous catheterization will be enrolled to the study.
Patients will be divided into either study group or control group. After anesthetic induction, central venous catheterization will be performed under ultrasound guidance. For patients in study group, the practitioner will be equipped with smart-glasses, while conventional ultrasound-guided catheterization will be performed for patients in control group.
Success rate of first trial, overall success rate, elapsed time during catheterization, complication regarding catheterization will be recorded and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are planned to undergo surgery under general anesthesia
- •Patients in need for central venous catheterization during anesthesia
排除标准
- •Patients who have any of infection, hematoma, skin lesion, recent attempt of puncture at right internal jugular vein
- •Patients with unstable vital sign prior to anesthetic induction
- •Patients who are not eligible for catheterization at right internal jugular vein
- •Refusal of legal guardian of patient
结局指标
主要结局
1st success rate
时间窗: From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 20 minutes.
Success rate of central venous catheterization in first trial
次要结局
- Elapsed time for catheterization(From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.)
- Overall success rate(From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 3 attempts and 20 minutes.)
- Complication(From end of catheterization to 24 hours after catheterization)
- Satisfaction score(From start of catheterization to end of catheterization. Not to exceed 20 minutes.)
研究者
Jin-Tae Kim
MD, PhD, Professor
Seoul National University Hospital