Manual Radial Compression Versus Gradual Pneumatic Compression for the Prevention of Radial Artery Occlusion After Transradial Cardiac Catheterization: A Pragmatic Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,168
- 试验地点
- 1
研究概览
简要总结
This study evaluates two commonly used methods of achieving hemostasis after transradial cardiac catheterization: manual compression and pneumatic compression with gradual deflation.
Transradial access is widely used for diagnostic and interventional cardiac procedures due to its safety profile, but radial artery occlusion remains a relevant complication that may limit future vascular access.
In this pragmatic, prospective, multicenter study conducted in routine clinical practice, adult patients undergoing transradial cardiac catheterization were assigned to receive either manual compression or pneumatic compression using a standardized patent hemostasis protocol. The primary objective is to compare the incidence of radial artery occlusion at 30 days between both strategies.
Secondary outcomes include local vascular complications, patient-reported pain, and total compression time.
详细描述
Transradial access has become the preferred approach for diagnostic and interventional coronary procedures due to its association with reduced bleeding complications, earlier mobilization, and shorter hospital stay compared with transfemoral access. However, radial artery occlusion (RAO) remains a relevant access-site complication that may limit future vascular access or the use of the radial artery as a conduit for coronary artery bypass grafting.
Hemostasis following radial sheath removal is a critical step in preserving arterial patency. Two commonly used strategies include manual compression using sterile gauze and non-circumferential adhesive dressing, and pneumatic compression using dedicated mechanical devices typically applied with gradual deflation protocols. Both approaches aim to achieve effective hemostasis while maintaining antegrade arterial flow, a concept known as patent hemostasis.
This study was designed as a pragmatic, prospective, multicenter interventional study conducted across eight hospitals in Spain, with central coordination from Hospital Clinic of Barcelona. The objective was to compare the effectiveness and safety of manual radial compression versus pneumatic compression with gradual deflation under standardized patent hemostasis protocols in real-world clinical practice.
Consecutive adult patients undergoing diagnostic or interventional cardiac catheterization via transradial access were included. After sheath removal, participants were assigned in a 1:1 predefined alternating sequence to either manual compression or pneumatic compression strategies.
In the manual compression group, hemostasis was achieved using direct pressure with sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency assessed by plethysmography. In the pneumatic compression group, a dedicated compression device was applied and gradually deflated according to a standardized protocol to achieve patent hemostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adults aged ≥18 years
- •Undergoing diagnostic or interventional cardiac catheterization via transradial access
- •Preserved dual hand circulation confirmed by Barbeau test
- •Ability to provide informed consent
- •Ability to complete 30-day follow-up
排除标准
- •Refusal to participate
- •Inability to complete follow-up
- •Abnormal collateral circulation (Barbeau type D)
- •Initial failure of radial access
- •Contraindication to prolonged radial compression
