Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Successful first-attempt vessel cannulation
研究概览
简要总结
Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.
详细描述
Use of needle guidance plus ultrasound imaging for CVC placement in the pediatric high-risk population may facilitate the procedure with a single needle pass and decrease the incidence of adverse effects by minimizing additional needle passes. This study will compare the use of ultrasound-only guidance with the Clear Guide SCENERGY guidance in terms of successful first-attempt vessel cannulations such as internal jugular and fermoral artery access. The question is whether it is possible to make ultrasound-guided pediatric vascular access less technically challenging in order to improve adoption and utilization leading to decreased iatrogenic complications and improved patient safety.
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
- None
盲法说明
Because the SCENERGY is an attachment to the ultrasound probe, it cannot be masked.
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any pediatric patient scheduled for a vessel cannulation at CNMC
排除标准
- 未提供
研究组 & 干预措施
Ultrasound-only Pediatric Vessel Cannulation
The standard of care for vessel cannulation currently employed at CNMC
SCENERGY-guided Pediatric Vessel Cannulation
The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations.
干预措施: SCENERGY (Device)
结局指标
主要结局
Successful first-attempt vessel cannulation
时间窗: 1 hour
Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel
次要结局
- Non-IR Personnel Successfully Cannulate Pediatric Patients(1 hour)
- Point-of-Care Successful Cannulation(1 hour)