Distal vs. Proximal Radial Artery Access for Cardiac Catheterization and Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)
研究概览
简要总结
This single-center, prospective, randomized study will evaluate distal radial artery (dRA) vs. proximal radial artery access (pRA) in regards to hand function and radial artery occlusion.
详细描述
Primary objective is to evaluate hand function following distal radial artery access compared to proximal artery access in patients undergoing cardiac catheterization.
Hand function will be assessed by:
- QuickDASH questionnaire
- Hand grip test
- Thumb forefinger pinch test utilizing a pinch gauge
Secondary objectives: Vascular access success rates, hematoma, bleeding, complications of vascular access and radial artery occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age ≥ 18 years.
- •The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound.
- •Patient should be able to comply with the protocol.
- •Provide written informed consent before study participation
排除标准
- •Obligatory femoral or forearm radial access
- •Previous ipsilateral forearm radial artery occlusion.
- •Patient on therapeutic oral anticoagulation.
- •Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands.
- •Enrolment in another study that competes or interferes with this study.
- •Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
- •Subject with planned complex PCI or procedure necessitating multiple intervention.
- •Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
- •History of stroke with residual deficit that affects hand function.
- •Previous radial artery catheterization within 1 year.
研究组 & 干预措施
Distal radial artery access
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
干预措施: Distal radial artery access (Procedure)
Proximal radial artery access
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
干预措施: Proximal radial artery surgery (Procedure)
结局指标
主要结局
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)
时间窗: 1 year
Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)
Thumb and Forefinger Pinch Strength Test
时间窗: 1 year
Hand function: Thumb and forefinger pinch strength (kg)
Hand Grip Strength Test
时间窗: 1 month
Hand grip strength test (kg)
次要结局
- Radial Artery Occlusion(1 year)
- Re-intervention Using the Radial Artery(1 year)