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Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

This study has been completed.
Sponsor:
Collaborators:
DS MAREF Co., Ltd.
Small and Medium Business Administration, KOREA
Information provided by (Responsible Party):
Jae-Sung Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01779648
First received: January 27, 2013
Last updated: April 24, 2013
Last verified: April 2013

January 27, 2013
April 24, 2013
March 2012
January 2013   (final data collection date for primary outcome measure)
Rate of Deep Vein Thrombosis [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.
Same as current
Complete list of historical versions of study NCT01779648 on ClinicalTrials.gov Archive Site
  • Peak Velocity [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    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.
  • Mean Velocity [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    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.
  • Peak Volume Flow [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    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.
  • Total Volume Flow [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    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.
  • Expelled Total Volume [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    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).
  • Expelled Peak Volume [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    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).
  • Augmented PV [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    Enhanced peak velocity by application of intermittent pneumatic compression
  • Augmented MV [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    Enhanced mean velocity by application of pneumatic compression
  • Augmented PVF [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    Enhanced peak volume flow by application of pneumatic compression
  • Augmented TVF [ Time Frame: on 4th postoperative day after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    Enhanced total volume flow by application of pneumatic compression
  • Cycling Rate [ Time Frame: on 4th postoperative day after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
    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.
Venous hemodynamic parameters [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ] [ Designated as safety issue: No ]
Doppler ultrasonography were performed to measure venous hemodynamic parameters like peak and mean venous velocities, total volume flow, and peak volume flow, in order to compare physiologic efficacies.
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Venous Thrombosis
  • Deep Vein Thrombosis
  • Device: DVT-3000
    Other Names:
    • Simultaneous sequential intermittent pneumatic compression
    • Fixed venous refill time
  • Device: SCD Express
    Other Names:
    • Alternate and sequential intermittent pneumatic comression
    • Adjusted venous refill time
  • Active Comparator: Simultaneous compression+Fixed refill time
    Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
    Intervention: Device: DVT-3000
  • Active Comparator: Alternate compression+Adjusted refill time
    alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
    Intervention: Device: SCD Express
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01779648
IPCDVT
Yes
Jae-Sung Choi, Seoul National University Hospital
Seoul National University Hospital
  • DS MAREF Co., Ltd.
  • Small and Medium Business Administration, KOREA
Principal Investigator: Jae-Sung Choi, Ph.D. SMG-SNU Boramae Medical Center
Seoul National University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP