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

K

Karolinska University Hospital

Status

Completed

Conditions

Deep Vein Thrombosis
Venous Stasis

Treatments

Device: Slow calf IPC
Device: Rapid calf IPC
Device: Foot IPC
Device: Calf NMES

Study type

Interventional

Funder types

Other

Identifiers

NCT03420625
SW2016-17-HEMOD

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 4 patient groups

Foot IPC
Active Comparator group
Description:
Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
Treatment:
Device: Foot IPC
Rapid calf IPC
Active Comparator group
Description:
Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
Treatment:
Device: Rapid calf IPC
Slow calf IPC
Active Comparator group
Description:
Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
Treatment:
Device: Slow calf IPC
Calf NMES
Active Comparator group
Description:
Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator
Treatment:
Device: Calf NMES

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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