Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Crossover Study of the Hemodynamic Effect of the OsciPulse Device Compared to Reference Therapies

Conditions
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Venous Thromboses, Venous Stasis

Intervention / Treatment
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* Device: OsciPulse system
* Device: Reference Therapy 1
* Device: Refence Therapy 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>In this single arm study all enrolled subjects will the intervention by the investigational device, and both reference devices. Ultrasound will be used to measure the blood flow in the subject during the use of all three devices. | Device: OsciPulse system<br>* 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.<br>Device: Reference Therapy 1<br>* 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.<br>* Other names: Venaflow Elite Vascular System;Device: Refence Therapy 2<br>* 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.<br>* Other names: Kendall 700 Series SCD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous valve sinus forward flow volume index | 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. | Visit 1 - 60 minutes | 
| Venous valve sinus reversing flow volume index | 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. | Visit 1 - 60 minutes | 
| Deep vein centerline flow | The velocity of venous flow measured by spectral Doppler ultrasound in the deep femoral vein. | Visit 1 - 60 minutes | 
| Venous valve sinus rouleaux | The degree of red blood cell rouleaux in the sinus of venous valves will be measured using B-mode ultrasound. | Visit 1 - 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous compression, Intermittent pneumatic compression