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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01779648
Enrollment
54
Registered
2013-01-30
Start date
2012-03-31
Completion date
2013-01-31
Last updated
2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Venous Thrombosis

Keywords

deep vein thrombosis, intermittent pneumatic compression, venous hemodynamics

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

Interventions

DEVICEDVT-3000
DEVICESCD Express

Sponsors

DS MAREF Co., Ltd.
CollaboratorUNKNOWN
Small and Medium Business Administration, KOREA
CollaboratorUNKNOWN
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Deep Vein ThrombosisOn 4th postoperative days after total knee replacement arthroplastyComputed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.

Secondary

MeasureTime frameDescription
Expelled Peak VolumeOn 4th postoperative days after total knee replacement arthroplastyExpelled 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).
Augmented PVOn 4th postoperative days after total knee replacement arthroplastyEnhanced peak velocity by application of intermittent pneumatic compression
Peak VelocityOn 4th postoperative days after total knee replacement arthroplastyDoppler 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 VelocityOn 4th postoperative days after total knee replacement arthroplastyDoppler 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.
Peak Volume FlowOn 4th postoperative days after total knee replacement arthroplastyDoppler 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.
Augmented MVOn 4th postoperative days after total knee replacement arthroplastyEnhanced mean velocity by application of pneumatic compression
Expelled Total VolumeOn 4th postoperative days after total knee replacement arthroplastyExpelled 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 PVFOn 4th postoperative days after total knee replacement arthroplastyEnhanced peak volume flow by application of pneumatic compression
Augmented TVFon 4th postoperative day after total knee replacement arthroplastyEnhanced total volume flow by application of pneumatic compression
Cycling Rateon 4th postoperative day after total knee replacement arthroplastyNumber 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.
Total Volume FlowOn 4th postoperative days after total knee replacement arthroplastyDoppler 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.

Countries

South Korea

Participant flow

Recruitment details

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.

Pre-assignment details

Two of them were excluded prior to group assignment because of the detection of a lung cancer and a deep vein thrombosis, respectively.

Participants by arm

ArmCount
Group SF
Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :
28
Group AA
alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
27
Total55

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation10

Baseline characteristics

CharacteristicGroup SFGroup AATotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
20 Participants26 Participants46 Participants
Age, Categorical
Between 18 and 65 years
8 Participants1 Participants9 Participants
Age Continuous68.0 years
STANDARD_DEVIATION 8.1
72.3 years
STANDARD_DEVIATION 5.9
70.1 years
STANDARD_DEVIATION 7.4
Body Mass Index
Female
27.1 kg/m2
STANDARD_DEVIATION 5.2
26.3 kg/m2
STANDARD_DEVIATION 4.4
26.7 kg/m2
STANDARD_DEVIATION 4.8
Body Mass Index
Male
26.5 kg/m2
STANDARD_DEVIATION 4.6
28.0 kg/m2
STANDARD_DEVIATION 1.6
27.4 kg/m2
STANDARD_DEVIATION 2.7
Region of Enrollment
Korea, Republic of
28 participants27 participants55 participants
Sex: Female, Male
Female
26 Participants24 Participants50 Participants
Sex: Female, Male
Male
2 Participants3 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
6 / 275 / 27
serious
Total, serious adverse events
0 / 270 / 27

Outcome results

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.

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

Population: One participant of Group SF dropped out of the analysis due to the device error; air leakage in the closed circuit system.

ArmMeasureGroupValue (NUMBER)
Group SFRate of Deep Vein Thrombosisbilateral development4 participants
Group SFRate of Deep Vein Thrombosisipsilateral development9 participants
Group SFRate of Deep Vein Thrombosisdistal DVT13 participants
Group SFRate of Deep Vein ThrombosisDeep vein thrombosis14 participants
Group SFRate of Deep Vein Thrombosisproximal DVT1 participants
Group SFRate of Deep Vein ThrombosisSymptomatic DVT0 participants
Group SFRate of Deep Vein Thrombosiscontralateral development1 participants
Group AARate of Deep Vein ThrombosisSymptomatic DVT0 participants
Group AARate of Deep Vein Thrombosiscontralateral development1 participants
Group AARate of Deep Vein ThrombosisDeep vein thrombosis15 participants
Group AARate of Deep Vein Thrombosisipsilateral development12 participants
Group AARate of Deep Vein Thrombosisbilateral development2 participants
Group AARate of Deep Vein Thrombosisdistal DVT14 participants
Group AARate of Deep Vein Thrombosisproximal DVT1 participants
p-value: 0.785Chi-squared
Secondary

Augmented MV

Enhanced mean velocity by application of pneumatic compression

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

ArmMeasureGroupValue (MEAN)Dispersion
Group SFAugmented MVright leg20.4 cm/secStandard Deviation 9.6
Group SFAugmented MVleft leg33.1 cm/secStandard Deviation 6.1
Group AAAugmented MVright leg18.2 cm/secStandard Deviation 4.7
Group AAAugmented MVleft leg18.3 cm/secStandard Deviation 6.1
Secondary

Augmented PV

Enhanced peak velocity by application of intermittent pneumatic compression

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

ArmMeasureGroupValue (MEAN)Dispersion
Group SFAugmented PVright62.8 cm/secStandard Deviation 17.8
Group SFAugmented PVleft57.1 cm/secStandard Deviation 20.2
Group AAAugmented PVright56.2 cm/secStandard Deviation 19.5
Group AAAugmented PVleft58.5 cm/secStandard Deviation 18.8
p-value: 0.929Mixed Models Analysis
Secondary

Augmented PVF

Enhanced peak volume flow by application of pneumatic compression

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

ArmMeasureGroupValue (MEAN)Dispersion
Group SFAugmented PVFright leg666.5 mL/minStandard Deviation 229.5
Group SFAugmented PVFleft leg602.7 mL/minStandard Deviation 302.8
Group AAAugmented PVFright leg514.6 mL/minStandard Deviation 465
Group AAAugmented PVFleft leg465.0 mL/minStandard Deviation 186.6
p-value: 0.008Mixed Models Analysis
Secondary

Augmented TVF

Enhanced total volume flow by application of pneumatic compression

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

ArmMeasureGroupValue (MEAN)Dispersion
Group SFAugmented TVFright leg400.7 mL/minStandard Deviation 188.2
Group SFAugmented TVFleft leg339.0 mL/minStandard Deviation 219.8
Group AAAugmented TVFright leg324.2 mL/minStandard Deviation 150.5
Group AAAugmented TVFleft leg271.2 mL/minStandard Deviation 135.8
p-value: 0.132Mixed Models Analysis
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.

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

ArmMeasureValue (MEAN)Dispersion
Group SFCycling Rate90 cycles/hourStandard Deviation 0
Group AACycling Rate78.9 cycles/hourStandard Deviation 20.4
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).

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

ArmMeasureGroupValue (MEAN)Dispersion
Group SFExpelled Peak Volumeright leg999.8 mL/hourStandard Deviation 344.3
Group SFExpelled Peak Volumeleft leg904.0 mL/hourStandard Deviation 454.2
Group AAExpelled Peak Volumeright leg633.1 mL/hourStandard Deviation 321.4
Group AAExpelled Peak Volumeleft leg525.5 mL/hourStandard Deviation 196.2
p-value: <0.001Mixed Models Analysis
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).

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

ArmMeasureGroupValue (MEAN)Dispersion
Group SFExpelled Total Volumeright leg7214.0 mL/hourStandard Deviation 3389.2
Group SFExpelled Total Volumeleft leg6102.8 mL/hourStandard Deviation 3957.6
Group AAExpelled Total Volumeright leg4342.0 mL/hourStandard Deviation 2419
Group AAExpelled Total Volumeleft leg3334.5 mL/hourStandard Deviation 1390.5
p-value: <0.001Mixed Models Analysis
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.

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

ArmMeasureValue (MEAN)Dispersion
Group SFMean Velocity10.0 cm/secStandard Deviation 2.5
Group AAMean Velocity9.7 cm/secStandard Deviation 2.7
Comparison: Mean of right and left leg values were compared between the two device groups.p-value: 0.722t-test, 2 sided
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.

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

ArmMeasureValue (MEAN)Dispersion
Group SFPeak Velocity24.8 cm/secStandard Deviation 5.9
Group AAPeak Velocity22.8 cm/secStandard Deviation 4.9
Comparison: Mean of right and left leg values were compared between the two device groups.p-value: 0.195t-test, 2 sided
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.

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

ArmMeasureValue (MEAN)Dispersion
Group SFPeak Volume Flow205.3 mL/minStandard Deviation 76.5
Group AAPeak Volume Flow176.4 mL/minStandard Deviation 72.1
Comparison: Mean of right and left leg values were compared between the two device groups.p-value: 0.158t-test, 2 sided
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.

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

ArmMeasureValue (MEAN)Dispersion
Group SFTotal Volume Flow160.9 mL/minStandard Deviation 58.1
Group AATotal Volume Flow144.2 mL/minStandard Deviation 59
Comparison: Mean of right and left leg values were compared between the two device groups.p-value: 0.301t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026