NCT01862471

Brief Summary

Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad. Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used outdated NMES devices. The objective of this study is to compare the effectiveness of a modern NMES device to intermittent pneumatic compression in terms of blood flow.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

May 22, 2013

Last Update Submit

June 19, 2013

Conditions

Venous Thrombosis

Keywords

Deep Vein ThrombosisNeuromuscular Electrical StimulationIntermittent Pneumatic CompressionDoppler Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Blood Flow Measurements from the Lower Limb

    An hour and a half (plus or minus half an hour)

Secondary Outcomes (2)

  • Blood Pressure

    An hour and a half (plus or minus half an hour)

  • Heart Rate

    An hour and a half (plus or minus half an hour)

Study Arms (1)

DVT prophylaxis

EXPERIMENTAL

Neuromuscular electrical stimulation using a custom-built, two-channel stimulator (Duo-STIM (stimulator), Bioelectronics Research Cluster, National University of Ireland, Galway) with a frequency of 36 Hz, a balanced biphasic waveform with a pulse width of 350μs, a ramp up time of 500ms, a contraction time of 1s and a ramp down time of 500ms. Stimulation was applied every 20 seconds over a period of 5 minutes. Intermittent pneumatic compression using the Novamedix A-V Impulse System Model 6000 (Novamedix distribution Limited, England), programmed to deliver compression every 20 seconds at a pressure of 130 mmHg for a 1 second duration over a period of 5 minutes.

Device: Neuromuscular Electrical StimulationDevice: Intermittent Pneumatic Compression

Interventions

Neuromuscular Electrical StimulationDEVICE

Frequency of 36Hz, a balanced biphasic waveform with a pulse width of 350μs, a ramp up time of 500ms, a contraction time of 1s and a ramp down time of 500ms.

Also known as: Custom-built, two-channel stimulator (Duo-STIM, Bioelectronics Research Cluster, NUI Galway)
DVT prophylaxis
Intermittent Pneumatic CompressionDEVICE

Programmed to deliver compression every 20 seconds at a pressure of 130mmHg for a 1 second duration over a period of 5 minutes.

Also known as: Novamedix AV Impulse System Model 6000 (Novamedix distribution Limited, England)
DVT prophylaxis

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • History of heart/respiratory problems
  • Pregnancy
  • Presence of implants, including cardiac pacemakers and orthopaedic implants
  • History of neurological disorder
  • History of severe arterial disease or known dermatological problems
  • Under 18 years of age or over 40 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Ireland, Galway

Galway, Ireland

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Gearoid OLaighin, PhD

    National University of Ireland, Galway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 24, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

IE(1)