Randomized Evaluation of Traditional Versus Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- number of puncture attempts
研究概览
简要总结
The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.
详细描述
A randomised study with an historical control group.
Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).
Only high-volume physicians who have passed a ultrasound course are allowed to include patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible
排除标准
- •Abnormal pulse oxymetry test
- •If severe lower-extremity calcification is known to exclude femoral access
研究组 & 干预措施
Ultrasound arm - Randomized group
Ultrasound guided sheath insertion
干预措施: Ultrasound guided sheath insertion (Diagnostic Test)
Conventional arm - Randomized group
Conventional arm during randomized phase
Historical control group
Conventional arm, non-randomization phase
结局指标
主要结局
number of puncture attempts
时间窗: during the procedure
Number of attempts to puncture the vessel as evaluated by the physician and by go-pro camera recordings
Placement of sheath
时间窗: during the procedure
Distance from proc.styloideus radius (radial procedure) or proximal part of caput femoris (femoral procedure) to vessel puncture site evaluated by angiography
Pain during sheath insertion and during the procedure
时间窗: during the procedure
Pain according to numerical rating scale during sheath insertion and during the procedure
Successfull procedure
时间窗: during the procedure
Proportion of patients where the procedure is completed according to prespecified access route (no conversion to femoral access if radial planned, and no conversion to radial access if femoral planned)
time of procedure
时间窗: during the procedure
time from administration of analgetics to removal of the sheath
次要结局
- Use of calcium blocker(during the procedure)
- Use of analgetics(during the procedure)
- Radial artery patency(during the procedure)
- Use of sedatives(during the procedure)
研究者
Christian Juhl Terkelsen
Associate professor
Aarhus University Hospital Skejby