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

Primary Purpose

Venous Stasis, Deep Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Foot IPC
Rapid calf IPC
Slow calf IPC
Calf NMES
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Venous Stasis focused on measuring Intermittent Pneumatic Compression Devices, Electric Stimulation Therapy, Blood Flow Velocity, Hemodynamics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Foot IPC

    Rapid calf IPC

    Slow calf IPC

    Calf NMES

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Blood Flow - Peak Systolic Velocity (cm/Sec)
    With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.
    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.
    Blood Flow - Volume Flow (ml/Min)
    With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 8, 2017
    Last Updated
    September 1, 2020
    Sponsor
    Karolinska University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03420625
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska University Hospital

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Stasis, Deep Vein Thrombosis
    Keywords
    Intermittent Pneumatic Compression Devices, Electric Stimulation Therapy, Blood Flow Velocity, Hemodynamics

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Foot IPC
    Arm Type
    Active Comparator
    Arm Description
    Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
    Arm Title
    Rapid calf IPC
    Arm Type
    Active Comparator
    Arm Description
    Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
    Arm Title
    Slow calf IPC
    Arm Type
    Active Comparator
    Arm Description
    Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
    Arm Title
    Calf NMES
    Arm Type
    Active Comparator
    Arm Description
    Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator
    Intervention Type
    Device
    Intervention Name(s)
    Foot IPC
    Other Intervention Name(s)
    Intermittent pneumatic compression in the foot
    Intervention Description
    Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
    Intervention Type
    Device
    Intervention Name(s)
    Rapid calf IPC
    Other Intervention Name(s)
    Rapid Intermittent pneumatic compression in the calf
    Intervention Description
    Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
    Intervention Type
    Device
    Intervention Name(s)
    Slow calf IPC
    Other Intervention Name(s)
    Slow Intermittent pneumatic compression in the calf
    Intervention Description
    Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
    Intervention Type
    Device
    Intervention Name(s)
    Calf NMES
    Other Intervention Name(s)
    Calf neuromuscular electrical stimulation
    Intervention Description
    Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
    Primary Outcome Measure Information:
    Title
    Blood Flow - Peak Systolic Velocity (cm/Sec)
    Description
    With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.
    Time Frame
    up to one hour in total
    Title
    Blood Flow - Time-averaged Mean Velocity (cm/Sec)
    Description
    With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.
    Time Frame
    up to one hour in total
    Title
    Blood Flow - Volume Flow (ml/Min)
    Description
    With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.
    Time Frame
    up to one hour in total
    Title
    Blood Flow - Ejected Volume Per Individual Stimulus (ml)
    Description
    With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.
    Time Frame
    up to one hour in total
    Secondary Outcome Measure Information:
    Title
    Tolerability to IPC and NMES According to Visual Analogue Scale 0-10
    Description
    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.
    Time Frame
    one minute

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

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

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