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OpenTrials
Completed

NCT Number: NCT02345642

A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

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.

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Key information

Conditions

Total Hip Arthroplasty

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ActiveCare+SFT Supine

Device

Other names: Portable Pneumatic Compression Device Supine

VenaFlow Elite Supine

Device

Other names: Stationary Pneumatic Compression Device Supine

ActiveCare+SFT Standing

Device

Other names: Portable Pneumatic Compression Device Standing

VenaFlow Elite Standing

Device

Other names: Stationary Pneumatic Compression Device Standing

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • DJO Incorporated

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 26, 2015
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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