Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

The Influence of the Different Ways of Pneumatic Compression on Clinical and Physiologic Efficacies in Preventing Deep Vein Thrombosis: a Randomised Comparative Study

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

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis; Deep Vein Thrombosis
• Intervention / Treatment: Device: DVT-3000; Device: SCD Express

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Simultaneous compression+Fixed refill time; Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression	Device: DVT-3000; Other Names: Simultaneous sequential intermittent pneumatic compression; Fixed venous refill time
ACTIVE_COMPARATOR: Alternate compression+Adjusted refill time; alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression	Device: SCD Express; Other Names: Alternate and sequential intermittent pneumatic comression; Adjusted venous refill time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Deep Vein Thrombosis	Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.	On 4th postoperative days after total knee replacement arthroplasty

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Velocity	Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Under fixed state of other ultrasound scan parameters, peak velocity (PV) was measured by determination of maximum point of the augmented waveform.	On 4th postoperative days after total knee replacement arthroplasty
Mean Velocity	Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Alternate compression arm) or 12 seconds (Simultaneous compression arm) were recorded. This is an automatically measured mean value of venous flow.	On 4th postoperative days after total knee replacement arthroplasty
Peak Volume Flow	Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Peak volume flow (PVF) was automatically calculated with 1-second interval around the PV.	On 4th postoperative days after total knee replacement arthroplasty
Total Volume Flow	Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Total volume flow (TVF) was automatically calculated by the software.	On 4th postoperative days after total knee replacement arthroplasty
Expelled Total Volume	Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled total volume (ETV) = single cycle augmented TVF x cycling rate (cycles/hour).	On 4th postoperative days after total knee replacement arthroplasty
Expelled Peak Volume	Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled peak volume (EPV) = single cycle augmented PVF x cycling rate (cycles/hour).	On 4th postoperative days after total knee replacement arthroplasty
Augmented PV	Enhanced peak velocity by application of intermittent pneumatic compression	On 4th postoperative days after total knee replacement arthroplasty
Augmented MV	Enhanced mean velocity by application of pneumatic compression	On 4th postoperative days after total knee replacement arthroplasty
Augmented PVF	Enhanced peak volume flow by application of pneumatic compression	On 4th postoperative days after total knee replacement arthroplasty
Augmented TVF	Enhanced total volume flow by application of pneumatic compression	on 4th postoperative day after total knee replacement arthroplasty
Cycling Rate	Number of cuff inflation-deflation cycle during an hour. In group SF, the cycling rate is fixed as 90 cycles/hour, but in group AA, it is variable according to the individual venous refill time.	on 4th postoperative day after total knee replacement arthroplasty

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: DS MAREF Co., Ltd.; Small and Medium Business Administration, KOREA
• Investigators: Principal Investigator: Jae-Sung Choi, Ph.D., SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: January 27, 2013
• First Submitted That Met QC Criteria: January 27, 2013
• First Posted (ESTIMATE): January 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 24, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: deep vein thrombosis; intermittent pneumatic compression; venous hemodynamics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: IPCDVT