Haemodynamic Effects of Different Mechanical Compression Devices and Neuromuscular Stimulation in the Lower Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Blood Flow - Peak Systolic Velocity (cm/Sec)
研究概览
简要总结
In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities in order to identify those which most effective than the others.
详细描述
Three Intermittent Pneumatic Compression (IPC) devices were selected: Foot-IPC, rapid Calf-IPC and a slow, sequential Calf-IPC. A Neuromuscular Electrical Stimulation (NMES) device was also used in the calf. Blood flow measurements in the right popliteal vein of ten healthy individuals were performed using Doppler ultrasound before (control) and while using IPC or NMES. The blood flow parameters measured where: peak systolic velocity (cm/s), time-averaged mean velocity (cm/sec), volume flow (ml/min) and ejected volume per individual stimulus (ml). The tolerability of each device was also assessed using an analogue scale from zero to ten. Differences between modalities regarding the pattern as well as the absolute values of velocity and volume are being assessed. Power calculation: Recent studies showed that the peak venous velocity (PV) at baseline is around 11 cm/s and after applying foot-IPC the PV rises to 50 cm/s with a maximum standard deviation of 15 (Broderick et all, 2014). Thus, three patients per group would be required to detect a difference of 39 cm/s in PV (two-sided type-I error rate = 5%; power = 80%). To reach an even higher power we choose to include 10 patients in study, which resulted in a power of 99.7% for the above calculation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
排除标准
- •pregnancy
- •previous lower limb operation involving the vascular system
- •current thromboprophylactic or thrombolytic therapy
- •vascular abnormalities in the lower limbs
- •cardiorespiratory or renal failure causing pitting oedema
研究组 & 干预措施
Foot IPC
Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
干预措施: Foot IPC (Device)
Rapid calf IPC
Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
干预措施: Rapid calf IPC (Device)
Slow calf IPC
Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
干预措施: Slow calf IPC (Device)
Calf NMES
Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator
干预措施: Calf NMES (Device)
结局指标
主要结局
Blood Flow - Peak Systolic Velocity (cm/Sec)
时间窗: up to one hour in total
With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.
Blood Flow - Ejected Volume Per Individual Stimulus (ml)
时间窗: up to one hour in total
With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.
Blood Flow - Time-averaged Mean Velocity (cm/Sec)
时间窗: up to one hour in total
With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.
Blood Flow - Volume Flow (ml/Min)
时间窗: up to one hour in total
With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.
次要结局
- Tolerability to IPC and NMES According to Visual Analogue Scale 0-10(one minute)
研究者
Paul Ackermann
Principal Investigator
Karolinska University Hospital
