Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779648
• Other study ID #: IPCDVT
• Status: Completed
• Phase: N/A
• First received: January 27, 2013
• Last updated: April 24, 2013
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• DVT-3000

• SCD Express

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (3)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	On 4th postoperative days after total knee replacement arthroplasty	No
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.	On 4th postoperative days after total knee replacement arthroplasty	No
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.	On 4th postoperative days after total knee replacement arthroplasty	No
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.	On 4th postoperative days after total knee replacement arthroplasty	No
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.	On 4th postoperative days after total knee replacement arthroplasty	No
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).	On 4th postoperative days after total knee replacement arthroplasty	No
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).	On 4th postoperative days after total knee replacement arthroplasty	No
Secondary	Augmented PV	Enhanced peak velocity by application of intermittent pneumatic compression	On 4th postoperative days after total knee replacement arthroplasty	No
Secondary	Augmented MV	Enhanced mean velocity by application of pneumatic compression	On 4th postoperative days after total knee replacement arthroplasty	No
Secondary	Augmented PVF	Enhanced peak volume flow by application of pneumatic compression	On 4th postoperative days after total knee replacement arthroplasty	No
Secondary	Augmented TVF	Enhanced total volume flow by application of pneumatic compression	on 4th postoperative day after total knee replacement arthroplasty	No
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.	on 4th postoperative day after total knee replacement arthroplasty	No