The Influence of the Different Ways of Pneumatic Compression on Clinical and Physiologic Efficacies in Preventing Deep Vein Thrombosis: a Randomised Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Rate of Deep Vein Thrombosis
研究概览
简要总结
Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of compression have been developed and used for prevention of deep vein thrombosis.
There are still some controversies about the physiologic properties and clinical impact of numerous issues including the variety of the cuff length, inflation rate, compression sequence, compression-relaxation cycle rate, and pressure generation characteristics.
This study is designed to compare clinical efficacies as well as venous hemodynamic improvements between Simultaneous bilateral compression with fixed venous refill time versus alternate compression with adjusted refill time
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients who undergo total knee replacement arthroplasty
排除标准
- •(1) chronic superficial or deep venous insufficiency, (2) venous anomalies like duplication of the superficial femoral vein, (3) previous venous thromboembolism history, (4) being under anticoagulation therapy, (5) severe arteriosclerosis obliterans without palpable dorsalis pedis pulse, (6) open fracture, hemorrhagic condition, or extensive dermatitis at lower legs, (7) congestive heart failure. Additional exclusion criteria included a documented malignant tumor, because pharmacologic prophylaxis with anticoagulants would be more reasonable in this case.
研究组 & 干预措施
Simultaneous compression+Fixed refill time
Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
干预措施: DVT-3000 (Device)
Alternate compression+Adjusted refill time
alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
干预措施: SCD Express (Device)
结局指标
主要结局
Rate of Deep Vein Thrombosis
时间窗: On 4th postoperative days after total knee replacement arthroplasty
Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.
次要结局
- Total Volume Flow(On 4th postoperative days after total knee replacement arthroplasty)
- Augmented PV(On 4th postoperative days after total knee replacement arthroplasty)
- Augmented PVF(On 4th postoperative days after total knee replacement arthroplasty)
- Augmented TVF(on 4th postoperative day after total knee replacement arthroplasty)
- Peak Velocity(On 4th postoperative days after total knee replacement arthroplasty)
- Mean Velocity(On 4th postoperative days after total knee replacement arthroplasty)
- Expelled Total Volume(On 4th postoperative days after total knee replacement arthroplasty)
- Augmented MV(On 4th postoperative days after total knee replacement arthroplasty)
- Cycling Rate(on 4th postoperative day after total knee replacement arthroplasty)
- Peak Volume Flow(On 4th postoperative days after total knee replacement arthroplasty)
- Expelled Peak Volume(On 4th postoperative days after total knee replacement arthroplasty)
研究者
Jae-Sung Choi
Associate Professior, Thoracic and Cardiovascular Department
Seoul National University Hospital