A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

Study Overview
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Brief Summary
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We are comparing two pneumatic compression devices, VenaFlow (stationary) and MCS (portable) in both the supine an standing position. We will start supine and will take 3 baseline measurements of venous velocity and then apply a device and take 3 measurements of the increase in peak venous velocity. We will repeat this with the second device. We will then have the subject stand and repeat the above with each device. We will randomize the order of the devices in the supine and standing position. This study will involve 10 healthy subjects of various ages and 10 total hip replacements (THR) patients.

Official Title
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A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

Conditions
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Total Hip Arthroplasty

Intervention / Treatment
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* Device: ActiveCare+SFT Supine
* Device: VenaFlow Elite Supine
* Device: ActiveCare+SFT Standing
* Device: VenaFlow Elite Standing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phase one: 10 healthy test subjects will be included of various ages. They will have each pneumatic compression device applied in the supine and then standing positions. Phase two: 10 patients following THR on postoperative day #2 will be included. These patients will agree to participate in the study and have to be able to stand for approximately 10 minutes. Exclusion Criteria: Patients with lymphedema Patients with peripheral vascular disease (chronic venous insufficiency) Patients who do not wish to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 Healthy Patients without THA<br>The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them. | Device: ActiveCare+SFT Supine<br> <br> * Other names: Portable Pneumatic Compression Device Supine;Device: VenaFlow Elite Supine<br> <br> * Other names: Stationary Pneumatic Compression Device Supine;Device: ActiveCare+SFT Standing<br> <br> * Other names: Portable Pneumatic Compression Device Standing;Device: VenaFlow Elite Standing<br> <br> * Other names: Stationary Pneumatic Compression Device Standing;|
| Experimental: 10 Patients with THA on Post-Op Day 2<br>The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2. | Device: ActiveCare+SFT Supine<br> <br> * Other names: Portable Pneumatic Compression Device Supine;Device: VenaFlow Elite Supine<br> <br> * Other names: Stationary Pneumatic Compression Device Supine;Device: ActiveCare+SFT Standing<br> <br> * Other names: Portable Pneumatic Compression Device Standing;Device: VenaFlow Elite Standing<br> <br> * Other names: Stationary Pneumatic Compression Device Standing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Venous Velocity | Ultrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded. | Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied |