N/A N=20 Randomized Prevention

A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices

Total Hip Arthroplasty

Bottom Line

View on ClinicalTrials.gov: NCT02345642 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Peak Venous Velocity — 127.9; 155.7; 87.1; 86.8 cm/s

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ActiveCare+SFT Supine (Device); VenaFlow Elite Supine (Device); ActiveCare+SFT Standing (Device); VenaFlow Elite Standing (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Venous Velocity	127.9; 155.7; 87.1; 86.8; 32.6; 41.9	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02345642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.