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Completed

NCT Number: NCT01779648

Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

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

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Deep Vein Thrombosis Embolism and Thrombosis Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DVT-3000

Device

Other names: Simultaneous sequential intermittent pneumatic compression, Fixed venous refill time

SCD Express

Device

Other names: Alternate and sequential intermittent pneumatic comression, Adjusted venous refill time

Primary outcomes

  1. Rate of Deep Vein Thrombosis

    Time frame: 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 outcomes

  1. Peak Velocity

    Time frame: 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.

  2. Mean Velocity

    Time frame: 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.

  3. Peak Volume Flow

    Time frame: 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.

  4. Total Volume Flow

    Time frame: 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.

  5. Expelled Total Volume

    Time frame: 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).

  6. Expelled Peak Volume

    Time frame: 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).

  7. Augmented PV

    Time frame: On 4th postoperative days after total knee replacement arthroplasty

    Enhanced peak velocity by application of intermittent pneumatic compression

  8. Augmented MV

    Time frame: On 4th postoperative days after total knee replacement arthroplasty

    Enhanced mean velocity by application of pneumatic compression

  9. Augmented PVF

    Time frame: On 4th postoperative days after total knee replacement arthroplasty

    Enhanced peak volume flow by application of pneumatic compression

  10. Augmented TVF

    Time frame: on 4th postoperative day after total knee replacement arthroplasty

    Enhanced total volume flow by application of pneumatic compression

  11. Cycling Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • DS MAREF Co., Ltd.
  • Small and Medium Business Administration, KOREA

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2013
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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