Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Venous Stasis, Deep Vein Thrombosis

Intervention / Treatment
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* Device: Foot IPC
* Device: Rapid calf IPC
* Device: Slow calf IPC
* Device: Calf NMES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Foot IPC<br>Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA | Device: Foot IPC<br>* Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA<br>* Other names: Intermittent pneumatic compression in the foot;|
| Active Comparator: Rapid calf IPC<br>Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA | Device: Rapid calf IPC<br>* Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA<br>* Other names: Rapid Intermittent pneumatic compression in the calf;|
| Active Comparator: Slow calf IPC<br>Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA | Device: Slow calf IPC<br>* Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA<br>* Other names: Slow Intermittent pneumatic compression in the calf;|
| Active Comparator: Calf NMES<br>Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator | Device: Calf NMES<br>* Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator<br>* Other names: Calf neuromuscular electrical stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Flow - Peak Systolic Velocity (cm/Sec) | With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein. | up to one hour in total | 
| Blood Flow - Time-averaged Mean Velocity (cm/Sec) | With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein. | up to one hour in total | 
| Blood Flow - Volume Flow (ml/Min) | With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein. | up to one hour in total | 
| Blood Flow - Ejected Volume Per Individual Stimulus (ml) | With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein. | up to one hour in total | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability to IPC and NMES According to Visual Analogue Scale 0-10 | All subjects will be asked to subjectively grade each modality according to how comfortable or uncomfortable it felt under the time was applied to the subject according to Visual Analogue Scale 0-10. The following description will be given to the subjects: 0 denotes the the modality was totally intolerable, 10 denotes that the modality is very pleasant to use and 5 denotes neither pleasant nor unpleasant feeling. | one minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent Pneumatic Compression Devices, Electric Stimulation Therapy, Blood Flow Velocity, Hemodynamics