Clinical trial NCT02345642: A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices
Official title: A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: DJO Incorporated
First posted: 2015-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak Venous Velocity
timeFrame: Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Lucian Warth, MD
role: STUDY_DIRECTOR
References:
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