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
  Purpose

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


Condition Intervention
Venous Thrombosis
Deep Vein Thrombosis
Device: DVT-3000
Device: SCD Express

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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 54
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Simultaneous compression+Fixed refill time
Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
Device: DVT-3000
Other Names:
  • Simultaneous sequential intermittent pneumatic compression
  • Fixed venous refill time
Active Comparator: Alternate compression+Adjusted refill time
alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
Device: SCD Express
Other Names:
  • Alternate and sequential intermittent pneumatic comression
  • Adjusted venous refill time

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779648

Locations
Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
DS MAREF Co., Ltd.
Small and Medium Business Administration, KOREA
Investigators
Principal Investigator: Jae-Sung Choi, Ph.D. SMG-SNU Boramae Medical Center
  More Information

No publications provided

Responsible Party: Jae-Sung Choi, Associate Professior, Thoracic and Cardiovascular Department, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01779648     History of Changes
Other Study ID Numbers: IPCDVT
Study First Received: January 27, 2013
Results First Received: February 23, 2013
Last Updated: April 24, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
deep vein thrombosis
intermittent pneumatic compression
venous hemodynamics

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on April 22, 2014