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临床试验/NCT03420625
NCT03420625已完成不适用

Haemodynamic Effects of Different Mechanical Compression Devices and Neuromuscular Stimulation in the Lower Limb

Karolinska University Hospital0 个研究点目标入组 10 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA

干预措施: Rapid calf IPC (Device)

Slow calf IPC

Active Comparator

Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA

干预措施: Slow calf IPC (Device)

Calf NMES

Active Comparator

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

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Ackermann

Principal Investigator

Karolinska University Hospital

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