Clinical trial NCT03420625: Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices
Official title: Haemodynamic Effects of Different Mechanical Compression Devices and Neuromuscular Stimulation in the Lower Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Stasis
Deep Vein Thrombosis
Keywords: Intermittent Pneumatic Compression Devices
Electric Stimulation Therapy
Blood Flow Velocity
Hemodynamics
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Flow - Peak Systolic Velocity (cm/Sec)
timeFrame: up to one hour in total
measure: Blood Flow - Time-averaged Mean Velocity (cm/Sec)
timeFrame: up to one hour in total
measure: Blood Flow - Volume Flow (ml/Min)
timeFrame: up to one hour in total
measure: Blood Flow - Ejected Volume Per Individual Stimulus (ml)
timeFrame: up to one hour in total
Secondary outcomes:
measure: Tolerability to IPC and NMES According to Visual Analogue Scale 0-10
timeFrame: one minute
Other outcomes:
Locations:
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