A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Blood Flow in the Lower Limb

This study is currently recruiting participants.
Verified February 2014 by National University of Ireland, Galway, Ireland
Sponsor:
Collaborators:
Irish Research Council
Galway Clinic
Information provided by (Responsible Party):
Gearoid O Laighin, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier:
NCT01894997
First received: July 3, 2013
Last updated: February 12, 2014
Last verified: February 2014

July 3, 2013
February 12, 2014
January 2014
April 2014   (final data collection date for primary outcome measure)
Blood flow measurements from the lower limb [ Time Frame: Two hours (plus or minus half an hour) ] [ Designated as safety issue: Yes ]
Doppler measurements will be taken for each of the interventions.The measurement site of interest is the popliteal vein, located at the back of the knee. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow will be recorded. 3 measurements of each will be taken per intervention. No measurements will be taken within the first minute of the intervention.
Blood flow measurements form the lower limb [ Time Frame: An hour and a half (plus or minus half an hour) ] [ Designated as safety issue: Yes ]
Doppler measurements will be taken for each of the interventions.The measurement site of interest is the popliteal vein, located at the back of the knee. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow will be recorded. 3 measurements of each will be taken per intervention. No measurements will be taken within the first minute of the intervention.
Complete list of historical versions of study NCT01894997 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: Two hours (plus or minus half an hour) ] [ Designated as safety issue: Yes ]
    Blood pressure will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.
  • Heart rate [ Time Frame: Two hours (plus or minus half an hour) ] [ Designated as safety issue: Yes ]
    Heart rate will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.
  • Blood pressure [ Time Frame: An hour and a half (plus or minus half an hour) ] [ Designated as safety issue: Yes ]
    Blood pressure will be measured throughout the study using a COLIN CBM-7000 non-invasive continuous blood pressure monitor.
  • Heart rate [ Time Frame: An hour and a half (plus or minus half an hour) ] [ Designated as safety issue: Yes ]
    Heart rate will be measured throughout the study using a COLIN CBM-7000 non-invasive continuous blood pressure monitor.
Not Provided
Not Provided
 
A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Blood Flow in the Lower Limb
A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Lower Limb Haemodynamics

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 dated NMES techniques.

The objective of this study is to compare the two methods in terms of blood flow, in both a young and an older population.

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) involves the use of an inflatable cuff placed around the limb. This cuff inflates and deflates intermittently in order to squeeze blood from the underlying veins. Neuromuscular Electrical Stimulation (NMES) leads to a contraction of muscles by delivering a series of controlled electrical pulses via skin surface electrodes placed over the motor points of the targeted muscle.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Venous Thrombosis
  • Device: Neuromuscular electrical stimulator
  • Device: AV Impulse System Model 6000
    Other Name: Intermittent Pneumatic Compression Device
Experimental: DVT Prophylaxis

Neuromuscular electrical stimulation is to be applied using a custom-built, two-channel 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 is to be applied every 20 seconds over a period of 5 minutes.

Intermittent pneumatic compression is to be applied 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 3 second duration over a period of 5 minutes.

Interventions:
  • Device: Neuromuscular electrical stimulator
  • Device: AV Impulse System Model 6000
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Free from any known illness
  • Between 18 and 40 years of age
  • Between 55 and 65 years of age

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
Both
18 Years to 65 Years
Yes
Contact: Gearoid OLaighin, PhD 35391494511 gearoid.olaighin@nuigalway.ie
Contact: Barry J Broderick, PhD 35391493126 barry.broderick@nuigalway.ie
Ireland
 
NCT01894997
EE-NMES-DVT-334
No
Gearoid O Laighin, National University of Ireland, Galway, Ireland
National University of Ireland, Galway, Ireland
  • Irish Research Council
  • Galway Clinic
Principal Investigator: Gearoid OLaighin, PhD National University of Ireland Galway
National University of Ireland, Galway, Ireland
February 2014

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