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
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
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
NCT ID
NCT03420625
First Posted
February 8, 2017
Last Updated
September 1, 2020
Sponsor
Karolinska University Hospital
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
Learn more about this trial
Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices
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