An interventional study of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Venous Thrombosis, sponsored by National University of Ireland, Galway, Ireland. Completed at 1 site in Ireland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-20.
Sponsored by National University of Ireland, Galway, Ireland · Not applicable, Interventional, and Prevention
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 However, few studies have directly compared the two methods and those that have, have used outdated NMES devices.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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 30 is below the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →National University of Ireland, Galway, Ireland is the lead sponsor of 46 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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Exclusion Criteria:
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 Stimulation · Device: Intermittent Pneumatic Compression
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)
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)
Blood Flow Measurements from the Lower Limb
Time frame: An hour and a half (plus or minus half an hour)
Blood Pressure
Time frame: An hour and a half (plus or minus half an hour)
Heart Rate
Time frame: An hour and a half (plus or minus half an hour)
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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National University of Ireland, Galway, Ireland