Venous Stasis, Venous Thromboses
Conditions
Keywords
Venous compression, Intermittent pneumatic compression
Brief summary
This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device. The study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobility, use of the OsciPulse system, and use of two reference vascular compression devices. Our hypothesis is that the OsciPulse system will create distinct patterns of venous flow, specifically at the site of venous valves, in comparison to the reference compression devices.
Detailed description
Enrolled healthy subjects will undergo and initial vascular ultrasound imaging procedure to locate a deep venous valve in either the sapheno-femoral junction or femoral trifurcation sites. Once the imaging valve is identified the baseline level of venous flow will be collected in 30 s video clips of 2D color Doppler videos and spectral Doppler. Next, either the OsciPulse device, or one of the two reference therapy devices, will be applied by study personnel according to the device's specific instructions. The subject will wear the device during the capture of 1 spectral Doppler clip and three 30 s 2D color Doppler ultrasound clips on both the left and right leg. Next, the remaining two devices will be applied based on instructions, and vascular ultrasound clips captured for each. Completion of this visit protocol will be the end of the study.
Interventions
DEVICEOsciPulse system
The OsciPulse system is an intermittent pneumatic limb compression system. The OsciPulse sleeves that are applied to the top portion of the user's calves and are periodically inflated with rapid bursts of compressed air to create frequent pulses of venous return.
DEVICEReference Therapy 1
The Venaflow Elite is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Venaflow system sleeves cover the entire calf region of the user and contain two bladders that are inflated sequentially to induce venous return.
DEVICERefence Therapy 2
The Kendall SCD device is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Kendall SCD sleeves cover the entire calf region of the user and contain three bladders that are inflated sequentially to induce venous return.
Sponsors
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
OsciFlex LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult age ≥40 years old * Generally healthy. * No history of diagnosed vascular disease including: DVT, PE, VTE, peripheral vascular disease, post-phlebitic syndrome, or chronic venous insufficiency. * Mentally alert and understand English proficiently. * Able to give informed consent.
Exclusion criteria
* Skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device or reference therapies. * Severe peripheral artery or venous disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous valve sinus forward flow volume index | Visit 1 - 60 minutes | The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving back towards the heart (forward flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips. |
| Venous valve sinus reversing flow volume index | Visit 1 - 60 minutes | The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving away from the heart (reversing flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips. |
| Deep vein centerline flow | Visit 1 - 60 minutes | The velocity of venous flow measured by spectral Doppler ultrasound in the deep femoral vein. |
| Venous valve sinus rouleaux | Visit 1 - 60 minutes | The degree of red blood cell rouleaux in the sinus of venous valves will be measured using B-mode ultrasound. |
Countries
United States
Outcome results
None listed