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

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ClinicalTrials.gov Identifier: NCT03420625
Recruitment Status : Completed
First Posted : February 2, 2018
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Venous Stasis Deep Vein Thrombosis Device: Foot IPC Device: Rapid calf IPC Device: Slow calf IPC Device: Calf NMES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Haemodynamic Effects of Different Mechanical Compression Devices and Neuromuscular Stimulation in the Lower Limb
Study Start Date : September 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Active Comparator: Foot IPC
Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
Device: Foot IPC
Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
Other Name: Intermittent pneumatic compression in the foot

Active Comparator: Rapid calf IPC
Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
Device: Rapid calf IPC
Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
Other Name: Rapid Intermittent pneumatic compression in the calf

Active Comparator: Slow calf IPC
Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
Device: Slow calf IPC
Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
Other Name: Slow Intermittent pneumatic compression in the calf

Active Comparator: Calf NMES
Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator
Device: Calf NMES
Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Other Name: Calf neuromuscular electrical stimulation




Primary Outcome Measures :
  1. Blood Flow - Peak Systolic Velocity (cm/Sec) [ Time Frame: up to one hour in total ]
    With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.

  2. Blood Flow - Time-averaged Mean Velocity (cm/Sec) [ Time Frame: up to one hour in total ]
    With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.

  3. Blood Flow - Volume Flow (ml/Min) [ Time Frame: up to one hour in total ]
    With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.

  4. Blood Flow - Ejected Volume Per Individual Stimulus (ml) [ Time Frame: up to one hour in total ]
    With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.


Secondary Outcome Measures :
  1. Tolerability to IPC and NMES According to Visual Analogue Scale 0-10 [ Time Frame: one minute ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Paul Ackermann, Principal Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03420625     History of Changes
Other Study ID Numbers: SW2016-17-HEMOD
First Posted: February 2, 2018    Key Record Dates
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019
Last Verified: January 2019

Keywords provided by Paul Ackermann, Karolinska University Hospital:
Intermittent Pneumatic Compression Devices
Electric Stimulation Therapy
Blood Flow Velocity
Hemodynamics

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Varicose Ulcer
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases