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| Name | Class |
|---|---|
| DS MAREF Co., Ltd. | UNKNOWN |
| Small and Medium Business Administration, KOREA | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous compression+Fixed refill time | Active Comparator | Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression |
|
| Alternate compression+Adjusted refill time | Active Comparator | alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVT-3000 | Device |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Sung Choi, Ph.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
Two of them were excluded prior to group assignment because of the detection of a lung cancer and a deep vein thrombosis, respectively.
The recruitment started in March, 2012 and ended in January, 2013. A total 57 participants were recruited and tested for enrollment after admission to the hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group SF | Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression Simultaneous compression +Fixed refill time: |
| FG001 | Group AA | alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression Alternate compression+Adjusted refill time |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group SF | Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression : |
| BG001 | Group AA | alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression : |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant of Group SF dropped out of the analysis due to the device error; air leakage in the closed circuit system. | Posted | Number | participants | On 4th postoperative days after total knee replacement arthroplasty |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group SF | Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression : |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| operative wound oozing | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | SMG-SNU Boramae Medical Center | +82-10-9988-2691 | turejsreal@hanmail.net |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| SCD Express | Device |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | cm/sec | On 4th postoperative days after total knee replacement arthroplasty |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | cm/sec | On 4th postoperative days after total knee replacement arthroplasty |
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| Secondary | 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. | Posted | Mean | Standard Deviation | mL/min | On 4th postoperative days after total knee replacement arthroplasty |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mL/min | On 4th postoperative days after total knee replacement arthroplasty |
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| Secondary | 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). | Posted | Mean | Standard Deviation | mL/hour | On 4th postoperative days after total knee replacement arthroplasty | limbs | Participants |
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| Secondary | 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). | Posted | Mean | Standard Deviation | mL/hour | On 4th postoperative days after total knee replacement arthroplasty | limbs | Participants |
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| Secondary | Augmented PV | Enhanced peak velocity by application of intermittent pneumatic compression | Posted | Mean | Standard Deviation | cm/sec | On 4th postoperative days after total knee replacement arthroplasty | limbs | Participants |
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| Secondary | Augmented MV | Enhanced mean velocity by application of pneumatic compression | Posted | Mean | Standard Deviation | cm/sec | On 4th postoperative days after total knee replacement arthroplasty | limbs | Participants |
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| Secondary | Augmented PVF | Enhanced peak volume flow by application of pneumatic compression | Posted | Mean | Standard Deviation | mL/min | On 4th postoperative days after total knee replacement arthroplasty | limbs | Participants |
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| Secondary | Augmented TVF | Enhanced total volume flow by application of pneumatic compression | Posted | Mean | Standard Deviation | mL/min | on 4th postoperative day after total knee replacement arthroplasty | limbs | Participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | cycles/hour | on 4th postoperative day after total knee replacement arthroplasty | limbs | Participants |
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|
| 0 |
| 27 |
| 6 |
| 27 |
| EG001 | Group AA | alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression : | 0 | 27 | 5 | 27 |
| wound pain aggravation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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