Clinical Study of the Application of Modified Ultrasound-Guided Dynamic Needle Tip Positioning Technique in Percutaneous Distal Radial Artery Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- First Needle Puncture Success Rate
研究概览
简要总结
The research project is focused on examining the clinical effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization. Anticipated results suggest that the improved ultrasound dynamic needle tip positioning method will surpass tactile guidance in terms of the success rate of the first puncture attempt, as well as overall puncture and catheterization success rates.
详细描述
The distal radial artery access route has several advantages; however, it comes with drawbacks like tortuous anatomy and a smaller lumen diameter. Compared to the wrist radial artery approach, it is more prone to spasm and has a lower success rate for puncture and catheterization. This clinical study aims to explore the effectiveness of an enhanced ultrasound dynamic needle tip positioning method for guiding distal radial artery puncture and catheterization.
In this prospective, randomized, single-center study, we will enroll 112 patients scheduled for percutaneous coronary angiography. They will be randomly assigned to either the control group (56 cases) or the study group (56 cases) using digital odd-even randomization. The control group will undergo conventional tactile guidance, while the study group will be guided by the improved ultrasound dynamic needle tip positioning method.
Parameters to be compared between the two groups include the success rate of the first puncture attempt, overall puncture success rate, number of puncture attempts, success rate of catheterization, time to successful catheterization, proportion of sheath sizes used, incidence of hematoma, and incidence of radial artery occlusion 24 hours post-procedure. The anticipated outcome is that the improved ultrasound dynamic needle tip positioning method will enhance the success rate of the first puncture attempt, overall puncture success rate, and catheterization success rate, while reducing the number of puncture attempts and operation time.
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18 and 85 who agree to undergo coronaroangiography
排除标准
- •Absence of radial artery pulsatility.
- •Abnormal Allen test.
- •Hemodynamic instability.
- •Preoperative ultrasound showing a distal radial artery diameter less than 1.8mm.
结局指标
主要结局
First Needle Puncture Success Rate
时间窗: Immediately after the puncture procedure
The proportion of participants who successfully achieve a first puncture into the radial artery on their first attempt.
Cannulation Success Rate
时间窗: Immediately after the cannulation procedure is completed
The proportion of participants who successfully achieve cannulation of the radial artery after a puncture attempt.
Puncture success rate
时间窗: Immediately after the puncture procedure
The proportion of participants who achieve successful puncture of the radial artery on their attempt
次要结局
- Distal Radial Hematoma Rate(Immediately after the puncture and again within 24 hours)
- Number of Punctures(Immediately after the puncture procedure)
- Puncture Success Time(Immediately after the puncture procedure)
- 24-Hour Proximal Radial Occlusion Rate(24 hours after the procedure)
- 24-Hour Distal Radial Occlusion Rate(24 hours after the procedure)
研究者
Yupeng Liang
Director
Guangdong Provincial Hospital of Traditional Chinese Medicine