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临床试验/NCT00114608
NCT00114608已完成1 期

Venous Blood Flow Velocity: Electrical Foot Stimulation Compared to Intermittent Pneumatic Compression of the Foot

University at Buffalo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Doppler venous blood flow velocity changes over 4 hours

研究概览

简要总结

Electrical stimulation of the foot can increase blood flow out of the leg. This increased blood flow can prevent blood clots from forming in the leg veins.

Blood clots in the leg veins can break off and form life-threatening blood clots in the lungs.

Intermittent external pneumatic (air) compression of the foot is already used to increase blood flow in at risk patients.

Hypothesis: Electrical stimulation of the foot increases blood flow out of the legs to the same degree as intermittent external pneumatic (air) compression of the foot.

详细描述

ABSTRACT Background: Venous stasis caused by immobility is an important risk factor for venous thromboembolic disease. This is especially true for orthopedic patients with multiple trauma and those undergoing other orthopedic procedures. A safe and convenient method for reducing venous stasis would be useful for preventing venous thrombosis in patients while in hospital and particularly after discharge during rehabilitation. In a prior study, we demonstrated that electrical stimulation of the foot was a safe and convenient method for counteracting venous stasis. In this study, we compare the effects on venous blood flow of intermittent pneumatic compression, an established method, to electrical stimulation of the foot.

Methods: 40 healthy volunteers aged 50 - 80 were seated for 4 hours during which they received mild electrical stimulation of the sole of the foot (plantar plexus of muscles) or intermittent pneumatic compression. Popliteal and femoral venous blood flow velocities were measured via Doppler ultrasound. Blood flow in the non-stimulated or non-compressed lower extremity served as a simultaneous control. Subjects completed a questionnaire regarding their acceptance and tolerance of both treatments.

INTRODUCTION Venous thrombosis and pulmonary embolism or venous thromboembolism (VTE) are important complications of medical and surgical conditions that are associated with prolonged immobilization. This is especially true for orthopedic patients with multiple trauma and those undergoing other orthopedic procedures. Immobilization is also a major contributor to the increased risk of VTE associated with prolonged air travel.

Despite good evidence that prophylaxis is effective, there is widespread under utilization of prophylaxis for VTE following major surgical procedures as well as medical conditions that produce weakness or prolonged bed rest. There is also good evidence that the risk of VTE continues for weeks after major orthopedic as well as other types of surgery. It is now recognized that VTE occurring in the hospital and outside the hospital setting is a single entity and that extended prophylaxis with anticoagulants reduces the risk.

Anticoagulant prophylaxis after hospital discharge although indicated in certain high risk groups is inconvenient since the recommended methods, LMWH and fondaparinux must be administered by subcutaneous injection and warfarin requires laboratory monitoring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers

排除标准

  • Venous or arterial disease of the lower limbs
  • Cardiac pacemaker
  • Known allergy to materials of surface electrodes
  • Neurologic disorder
  • Lower extremity fracture history
  • History of joint replacement surgery
  • Anticoagulation therapy other than aspirin

结局指标

主要结局

Doppler venous blood flow velocity changes over 4 hours

时间窗: Two, 4 hour sessions

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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