Trial Outcomes & Findings for Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis (NCT NCT01779648)

NCT ID: NCT01779648

Last Updated: 2013-05-01

Results Overview

Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: On 4th postoperative days after total knee replacement arthroplasty
• Results posted on: 2013-05-01

Participant Flow

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.

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

Participant milestones

Measure	Group SF Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression Simultaneous compression +Fixed refill time:	Group AA alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression Alternate compression+Adjusted refill time
Overall Study STARTED	28	27
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Group SF Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression Simultaneous compression +Fixed refill time:	Group AA alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression Alternate compression+Adjusted refill time
Overall Study Protocol Violation	1	0

Baseline Characteristics

Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

Baseline characteristics by cohort

Measure	Group SF n=28 Participants Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=27 Participants alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Age Continuous	68.0 years STANDARD_DEVIATION 8.1 • n=5 Participants	72.3 years STANDARD_DEVIATION 5.9 • n=7 Participants	70.1 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Korea, Republic of	28 participants n=5 Participants	27 participants n=7 Participants	55 participants n=5 Participants
Body Mass Index Female	27.1 kg/m2 STANDARD_DEVIATION 5.2 • n=5 Participants	26.3 kg/m2 STANDARD_DEVIATION 4.4 • n=7 Participants	26.7 kg/m2 STANDARD_DEVIATION 4.8 • n=5 Participants
Body Mass Index Male	26.5 kg/m2 STANDARD_DEVIATION 4.6 • n=5 Participants	28.0 kg/m2 STANDARD_DEVIATION 1.6 • n=7 Participants	27.4 kg/m2 STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.

Outcome measures

Measure	Group SF n=27 Participants Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=27 Participants alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Rate of Deep Vein Thrombosis Deep vein thrombosis	14 participants	15 participants
Rate of Deep Vein Thrombosis ipsilateral development	9 participants	12 participants
Rate of Deep Vein Thrombosis contralateral development	1 participants	1 participants
Rate of Deep Vein Thrombosis bilateral development	4 participants	2 participants
Rate of Deep Vein Thrombosis distal DVT	13 participants	14 participants
Rate of Deep Vein Thrombosis proximal DVT	1 participants	1 participants
Rate of Deep Vein Thrombosis Symptomatic DVT	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group SF n=27 Participants Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=27 Participants alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Peak Velocity	24.8 cm/sec Standard Deviation 5.9	22.8 cm/sec Standard Deviation 4.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group SF n=27 Participants Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=27 Participants alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Mean Velocity	10.0 cm/sec Standard Deviation 2.5	9.7 cm/sec Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group SF n=27 Participants Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=27 Participants alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Peak Volume Flow	205.3 mL/min Standard Deviation 76.5	176.4 mL/min Standard Deviation 72.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group SF n=27 Participants Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=27 Participants alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Total Volume Flow	160.9 mL/min Standard Deviation 58.1	144.2 mL/min Standard Deviation 59.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Group SF n=54 limbs Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=54 limbs alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Expelled Total Volume right leg	7214.0 mL/hour Standard Deviation 3389.2	4342.0 mL/hour Standard Deviation 2419.0
Expelled Total Volume left leg	6102.8 mL/hour Standard Deviation 3957.6	3334.5 mL/hour Standard Deviation 1390.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Group SF n=54 limbs Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=54 limbs alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Expelled Peak Volume right leg	999.8 mL/hour Standard Deviation 344.3	633.1 mL/hour Standard Deviation 321.4
Expelled Peak Volume left leg	904.0 mL/hour Standard Deviation 454.2	525.5 mL/hour Standard Deviation 196.2

SECONDARY outcome

Timeframe: On 4th postoperative days after total knee replacement arthroplasty

Enhanced peak velocity by application of intermittent pneumatic compression

Outcome measures

Measure	Group SF n=54 limbs Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=54 limbs alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Augmented PV right	62.8 cm/sec Standard Deviation 17.8	56.2 cm/sec Standard Deviation 19.5
Augmented PV left	57.1 cm/sec Standard Deviation 20.2	58.5 cm/sec Standard Deviation 18.8

SECONDARY outcome

Timeframe: On 4th postoperative days after total knee replacement arthroplasty

Enhanced mean velocity by application of pneumatic compression

Outcome measures

Measure	Group SF n=54 limbs Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=54 limbs alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Augmented MV right leg	20.4 cm/sec Standard Deviation 9.6	18.2 cm/sec Standard Deviation 4.7
Augmented MV left leg	33.1 cm/sec Standard Deviation 6.1	18.3 cm/sec Standard Deviation 6.1

SECONDARY outcome

Timeframe: On 4th postoperative days after total knee replacement arthroplasty

Enhanced peak volume flow by application of pneumatic compression

Outcome measures

Measure	Group SF n=54 limbs Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=54 limbs alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Augmented PVF right leg	666.5 mL/min Standard Deviation 229.5	514.6 mL/min Standard Deviation 465.0
Augmented PVF left leg	602.7 mL/min Standard Deviation 302.8	465.0 mL/min Standard Deviation 186.6

SECONDARY outcome

Timeframe: on 4th postoperative day after total knee replacement arthroplasty

Enhanced total volume flow by application of pneumatic compression

Outcome measures

Measure	Group SF n=54 limbs Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=54 limbs alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Augmented TVF right leg	400.7 mL/min Standard Deviation 188.2	324.2 mL/min Standard Deviation 150.5
Augmented TVF left leg	339.0 mL/min Standard Deviation 219.8	271.2 mL/min Standard Deviation 135.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Group SF n=54 limbs Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=54 limbs alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Cycling Rate	90 cycles/hour Standard Deviation 0	78.9 cycles/hour Standard Deviation 20.4

Adverse Events

Group SF

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Group AA

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group SF n=27 participants at risk Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression simultaneous compression :	Group AA n=27 participants at risk alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression alternate compression :
Musculoskeletal and connective tissue disorders operative wound oozing	3.7% 1/27	3.7% 1/27
Musculoskeletal and connective tissue disorders wound pain aggravation	18.5% 5/27	14.8% 4/27

Additional Information

Principal Investigator

SMG-SNU Boramae Medical Center

Phone: +82-10-9988-2691

Email: turejsreal@hanmail.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place