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

This study has been completed.
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: September 2, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Venous Thrombosis
Device: Neuromuscular electrical stimulator
Device: AV Impulse System Model 6000

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Lower Limb Haemodynamics

Resource links provided by NLM:


Further study details as provided by National University of Ireland, Galway, Ireland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: January 2014
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Device: Neuromuscular electrical stimulator Device: AV Impulse System Model 6000
Other Name: Intermittent Pneumatic Compression Device

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894997

Locations
Ireland
National University of Ireland, Galway
Galway, Ireland
Sponsors and Collaborators
National University of Ireland, Galway, Ireland
Irish Research Council
Galway Clinic
Investigators
Principal Investigator: Gearoid OLaighin, PhD National University of Ireland Galway
  More Information

No publications provided

Responsible Party: Gearoid O Laighin, Professor, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT01894997     History of Changes
Other Study ID Numbers: EE-NMES-DVT-334
Study First Received: July 3, 2013
Last Updated: September 2, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by National University of Ireland, Galway, Ireland:
Deep Vein Thrombosis
Neuromuscular Electrical Stimulation
Intermittent Pneumatic Compression
Doppler Ultrasound

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

ClinicalTrials.gov processed this record on October 20, 2014