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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-02-28

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.

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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.

Conditions

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Venous Stasis Deep Vein Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Foot IPC

Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA

Group Type ACTIVE_COMPARATOR

Foot IPC

Intervention Type DEVICE

Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA

Rapid calf IPC

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

Group Type ACTIVE_COMPARATOR

Rapid calf IPC

Intervention Type DEVICE

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

Slow calf IPC

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

Group Type ACTIVE_COMPARATOR

Slow calf IPC

Intervention Type DEVICE

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

Calf NMES

Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator

Group Type ACTIVE_COMPARATOR

Calf NMES

Intervention Type DEVICE

Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator

Interventions

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Foot IPC

Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA

Intervention Type DEVICE

Rapid calf IPC

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

Intervention Type DEVICE

Slow calf IPC

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

Intervention Type DEVICE

Calf NMES

Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator

Intervention Type DEVICE

Other Intervention Names

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Intermittent pneumatic compression in the foot Rapid Intermittent pneumatic compression in the calf Slow Intermittent pneumatic compression in the calf Calf neuromuscular electrical stimulation

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes