Skip to main content
OpenTrials
Completed

NCT Number: NCT01862471

Neuromuscular Electrical Stimulation Versus Intermittent Pneumatic Compression for Blood Flow

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 However, few studies have directly compared the two methods and those that have, have used outdated NMES devices.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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Ireland, Galway

Galway, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

  • 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

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

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.

Other names: Custom-built, two-channel stimulator (Duo-STIM, Bioelectronics Research Cluster, NUI Galway)

intermittent pneumatic compression

Device

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

Other names: Novamedix AV Impulse System Model 6000 (Novamedix distribution Limited, England)

Primary outcomes

  1. Blood Flow Measurements from the Lower Limb

    Time frame: An hour and a half (plus or minus half an hour)

Secondary outcomes

  1. Blood Pressure

    Time frame: An hour and a half (plus or minus half an hour)

  2. Heart Rate

    Time frame: An hour and a half (plus or minus half an hour)

Sponsors and collaborators

Lead sponsor

National University of Ireland, Galway, Ireland

Other

Collaborators

  • Irish Research Council

Registry information

Official study title

Improved Lower Limb Haemodynamics Using Neuromuscular Electrical Stimulation (NMES); Potential Novel DVT Prophylaxis

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 24, 2013
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.