A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

September 13, 2017 updated by: Hospital for Special Surgery, New York
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10 Healthy Patients without THA
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
Other Names:
  • Portable Pneumatic Compression Device Supine
Device: VenaFlow Elite Supine
Other Names:
  • Stationary Pneumatic Compression Device Supine
Device: ActiveCare+SFT Standing
Other Names:
  • Portable Pneumatic Compression Device Standing
Device: VenaFlow Elite Standing
Other Names:
  • Stationary Pneumatic Compression Device Standing
Experimental: 10 Patients with THA on Post-Op Day 2
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
Other Names:
  • Portable Pneumatic Compression Device Supine
Device: VenaFlow Elite Supine
Other Names:
  • Stationary Pneumatic Compression Device Supine
Device: ActiveCare+SFT Standing
Other Names:
  • Portable Pneumatic Compression Device Standing
Device: VenaFlow Elite Standing
Other Names:
  • Stationary Pneumatic Compression Device Standing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Venous Velocity
Time Frame: Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

DJO Incorporated

Investigators

  • Study Director: Lucian Warth, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 14064 (Other Identifier: Stanford IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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