Influence of the Compression Method After Transradial Catheterization in Radial Artery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Determination of radial artery occlusion after catheterization
研究概览
简要总结
The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility.
详细描述
Changes in Allen's test and pulse oximetry will be evaluated at baseline, 1 week and 3 month of catheterization in both groups of patients in order to check the functionality of the communications between the ulnar and radial arteries. The repercussion of each compressive method on radial occlusion and artery revascularization will be assessed by eco-Doppler at any time. Changes in diameter of arterial lumen of radial and ulnar arteries as a consequence of radial occlusion will be done simultaneously of blood flow Doppler measurements. The possible impact of radial occlusion on hand mobility will be done using a dynamometer designed to evaluate strength (Endurance test) and muscular claudication (Rapid exchange test).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom at least the diagnostic catheterization has been done successfully by the radial artery route.
- •Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse.
- •Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
- •Patients that will be able to do the follow up visits at 1 week and 3 month.
- •Signature of informed consent
排除标准
- •Patients in that neither the diagnostic or therapeutic procedure has successfully done via the radial artery route.
- •Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse.
- •Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse.
- •Inability to visit at 1 week and 3 month.
- •Impossibility to obtain informed consent form
研究组 & 干预措施
Terumo
Patients in this arm will receive Terumo after catheterization
干预措施: Terumo (Other)
Tensoplast
Patients in this arm will receive Tensoplast after catheterization
干预措施: Tensoplast (Other)
结局指标
主要结局
Determination of radial artery occlusion after catheterization
时间窗: 3 month
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Determination of radial artery occlusion at baseline (before catheterization)
时间窗: 1 day
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
Determination of radial artery occlusion after catheterization
时间窗: 1 week
Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods
次要结局
- Anatomic differences in radial and ulnar diameters(3 month)
- Differences in functional status between occluded radial cohort and patent radial cohort(3 month)
- Differences in functional status at follow between compression groups(3 month)
- Differences in radial and ulnar blood flow between compression methods(3 month)
- Differences in functional status at follow between compression groups(1 day)
- Differences in functional status at follow between compression groups(1 week)
- Differences in functional status between occluded radial cohort and patent radial cohort(1 day)
- Differences in functional status between occluded radial cohort and patent radial cohort(1 week)