Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis; Venous Thrombosis
• Interventions: Device: DVT-3000; Device: SCD Express

• Registration Number: NCT01779648
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-01-27
• Study First Submitted QC: 2013-01-27
• Study First Posted: 2013-01-30
• Results First Submitted: 2013-02-23
• Results First Submitted QC: 2013-02-23
• Status Verified: 2013-04
• Results First Posted: 2013-04-10
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• the patients who undergo total knee replacement arthroplasty

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simultaneous compression+Fixed refill time	DVT-3000	Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
Alternate compression+Adjusted refill time	SCD Express	alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total Volume Flow	On 4th postoperative days after total knee replacement arthroplasty	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.
Augmented PV	On 4th postoperative days after total knee replacement arthroplasty	Enhanced peak velocity by application of intermittent pneumatic compression
Augmented PVF	On 4th postoperative days after total knee replacement arthroplasty	Enhanced peak volume flow by application of pneumatic compression
Augmented TVF	on 4th postoperative day after total knee replacement arthroplasty	Enhanced total volume flow by application of pneumatic compression
Peak Velocity	On 4th postoperative days after total knee replacement arthroplasty	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.
Mean Velocity	On 4th postoperative days after total knee replacement arthroplasty	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.
Expelled Total Volume	On 4th postoperative days after total knee replacement arthroplasty	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).
Augmented MV	On 4th postoperative days after total knee replacement arthroplasty	Enhanced mean velocity by application of pneumatic compression
Cycling Rate	on 4th postoperative day after total knee replacement arthroplasty	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.
Peak Volume Flow	On 4th postoperative days after total knee replacement arthroplasty	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.
Expelled Peak Volume	On 4th postoperative days after total knee replacement arthroplasty	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).

Trial Locations

Locations (1)

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of