Comparison of the Ultrasound-guided Axillary Vein Puncture With the Conventional Cephalic Vein Cut-down Technique for Implantation of Cardiac Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Rate of successful cardiac device implantation
研究概览
简要总结
The implantation of cardiac electronic devices is a common procedure in the Electrophysiology Laboratory. The most commonly used venous access sites are the cephalic, the axillary and the subclavian vein.
Studies comparing these options have been conducted in the past. Axillary venous access can be achieved either through axillary vein angiography or by ultrasound guidance. Nevertheless, appropriate training is required for the ultrasound-guided axillary puncture technique-as well as for the cephalic vein cutdown technique.
Data from randomized trials regarding direct comparison of the two methods in terms of efficacy and safety are very limited.
The purpose of the study is the comparison of the efficacy and safety of the ultrasound-guided axillary venous access technique versus the cephalic venous access using the cut-down technique in patients requiring intravenous cardiac device (single-chamber/dual-chamber pacemaker/defibrillator) implantation.
详细描述
This study is a single-center, randomized, clinical trial. Its purpose is the comparison of the ultrasound-guided axillary venous access technique versus the cephalic venous access using the cut-down technique in cardiac device implantation procedures. Prerequisite for starting patients' recruitment is that the operators have undergone a training phase in ultrasound-guided axillary vein puncture in the Interventional Radiology Laboratory and have completed at least 30 procedures. A GE V-scan device with a special linear transducer for vessel examination will be utilized for the ultrasound guidance. Micropuncture technique will be performed for venous access.
Eligibility criteria:
Inclusion criteria
- Age ≥ 18 years
- Indication for single- or dual-chamber pacemaker of defibrillator implantation
- Written informed consent Exclusion criteria
- Indication for biventricular pacemaker or defibrillator
- Upgrade in pacing or defibrillation system
After the operators' training phase, candidates for pacemaker or defibrillator (single- or dual-chamber) implantation who fulfill the inclusion criteria will be randomly assigned with 1:1 allocation to one of the Groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age ≥ 18 years
- •Indication for single- or dual-chamber pacemaker of defibrillator implantation
- •Written informed consent
排除标准
- •Indication for biventricular pacemaker/defibrillator
- •Upgrade in pacing or defibrillation system
结局指标
主要结局
Rate of successful cardiac device implantation
时间窗: Intervention time (Day 0)
次要结局
- Duration of lead insertion procedure(Intervention time (Day 0))
- Radiation dose(Intervention time (Day 0))
- Total procedure duration(Intervention time (Day 0))
- Procedure-related complication rate (pneumothorax, cardiac tamponade, pocket hematoma, lead displacement, fever, need for antibiotic treatment)(Day 0-30)
- Fluoroscopy time(Intervention time (Day 0))
- Pain associated with the procedure assessed by use of the visual analogue pain scale from 0 to 10 (0: no pain, 10: worse pain)(Day 1)
- Duration of hospitalization(Through study completion, an average of 1.5 year)
研究者
Georgios Leventopoulos
Consultant Cardiologist
University Hospital of Patras