Clinical trial NCT01779648: Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis
Official title: The Influence of the Different Ways of Pneumatic Compression on Clinical and Physiologic Efficacies in Preventing Deep Vein Thrombosis: a Randomised Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thrombosis
Deep Vein Thrombosis
Keywords: deep vein thrombosis
intermittent pneumatic compression
venous hemodynamics
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: DS MAREF Co., Ltd.
name: Small and Medium Business Administration, KOREA
First posted: 2013-01-30
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of compression have been developed and used for prevention of deep vein thrombosis.

There are still some controversies about the physiologic properties and clinical impact of numerous issues including the variety of the cuff length, inflation rate, compression sequence, compression-relaxation cycle rate, and pressure generation characteristics.

This study is designed to compare clinical efficacies as well as venous hemodynamic improvements between Simultaneous bilateral compression with fixed venous refill time versus alternate compression with adjusted refill time


Eligibility criteria: Inclusion Criteria:

* the patients who undergo total knee replacement arthroplasty

Exclusion Criteria:

* (1) chronic superficial or deep venous insufficiency, (2) venous anomalies like duplication of the superficial femoral vein, (3) previous venous thromboembolism history, (4) being under anticoagulation therapy, (5) severe arteriosclerosis obliterans without palpable dorsalis pedis pulse, (6) open fracture, hemorrhagic condition, or extensive dermatitis at lower legs, (7) congestive heart failure. Additional exclusion criteria included a documented malignant tumor, because pharmacologic prophylaxis with anticoagulants would be more reasonable in this case.

Primary outcomes:
measure: Rate of Deep Vein Thrombosis
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
Secondary outcomes:
measure: Peak Velocity
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Mean Velocity
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Peak Volume Flow
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Total Volume Flow
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Expelled Total Volume
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Expelled Peak Volume
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Augmented PV
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Augmented MV
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Augmented PVF
timeFrame: On 4th postoperative days after total knee replacement arthroplasty
measure: Augmented TVF
timeFrame: on 4th postoperative day after total knee replacement arthroplasty
measure: Cycling Rate
timeFrame: on 4th postoperative day after total knee replacement arthroplasty
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jae-Sung Choi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: