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临床试验/NCT01886612
NCT01886612已完成不适用

A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Haemodynamics

National University of Ireland, Galway, Ireland1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Blood Flow Measurements from the Lower Limb

研究概览

简要总结

Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used dated NMES techniques.

The objective of this study is to compare the two methods in terms of blood flow.

详细描述

Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent Pneumatic Compression (IPC) involves the use of an inflatable cuff placed around the limb. This cuff inflates and deflates intermittently in order to squeeze blood from the underlying veins. Neuromuscular Electrical Stimulation (NMES) leads to a contraction of muscles by delivering a series of controlled electrical pulses via skin surface electrodes placed over the motor points of the targeted muscle.

Both IPC and NMES have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used dated NMES techniques.

The objective of this study is to compare the two methods in terms of lower limb haemodynamics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Free from any known illness.
  • Between 18 and 40 years of age.

排除标准

  • History of heart/respiratory problems
  • Pregnancy
  • Presence of implants, including cardiac pacemakers or orthopaedic implants
  • History of a neurological disorder
  • History of severe arterial disease or known dermatological problems.

结局指标

主要结局

Blood Flow Measurements from the Lower Limb

时间窗: An hour and a half (plus or minus half an hour)

Doppler measurements must be taken for each of the interventions. The measurement site of interest is the popliteal vein, located at the lateral aspect of the knee, below the sapheno-popliteal junction. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow are required. A minimum of 3 measurements per intervention is required for rigor. Do not take any measurement within the first minute of the intervention

次要结局

  • Blood Pressure(An hour and a half (plus or minus half an hour))
  • Heart Rate(An hour and a half (plus or minus half an hour))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gearoid O Laighin

Professor

National University of Ireland, Galway, Ireland

研究点 (1)

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