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A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow

Primary Purpose

Venous Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Duo-STIM neuromuscular electrical stimulator
AV Impulse System Model 6000
Sponsored by
National University of Ireland, Galway, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thrombosis focused on measuring Deep Vein Thrombosis, Neuromuscular Electrical Stimulation, Intermittent Pneumatic Compression, Doppler Ultrasound

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • History of heart/respiratory problems
  • Pregnancy
  • Presence of implants, including cardiac pacemakers or orthopaedic implants
  • History of a neurological disorder
  • History of severe arterial disease or known dermatological problems.

Sites / Locations

  • National University of Ireland, Galway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DVT Prophylaxis

Arm Description

Neuromuscular electrical stimulation is to be applied 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 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 1 second duration over a period of 5 minutes.

Outcomes

Primary Outcome Measures

Blood Flow Measurements from the Lower Limb
Doppler measurements must be taken for each of the interventions. The measurement site of interest is the popliteal vein, located at the lateral aspect of the knee, below the sapheno-popliteal junction. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow are required. A minimum of 3 measurements per intervention is required for rigor. Do not take any measurement within the first minute of the intervention

Secondary Outcome Measures

Blood Pressure
Heart Rate

Full Information

First Posted
June 21, 2013
Last Updated
August 1, 2013
Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Irish Research Council, Galway Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01886612
Brief Title
A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow
Official Title
A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Haemodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Irish Research Council, Galway Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 dated NMES techniques. The objective of this study is to compare the two methods in terms of blood flow.
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. Both IPC and 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 lower limb haemodynamics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis
Keywords
Deep Vein Thrombosis, Neuromuscular Electrical Stimulation, Intermittent Pneumatic Compression, Doppler Ultrasound

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DVT Prophylaxis
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation is to be applied 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 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 1 second duration over a period of 5 minutes.
Intervention Type
Device
Intervention Name(s)
Duo-STIM neuromuscular electrical stimulator
Intervention Type
Device
Intervention Name(s)
AV Impulse System Model 6000
Other Intervention Name(s)
Intermittent Pneumatic Compression Device
Primary Outcome Measure Information:
Title
Blood Flow Measurements from the Lower Limb
Description
Doppler measurements must be taken for each of the interventions. The measurement site of interest is the popliteal vein, located at the lateral aspect of the knee, below the sapheno-popliteal junction. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow are required. A minimum of 3 measurements per intervention is required for rigor. Do not take any measurement within the first minute of the intervention
Time Frame
An hour and a half (plus or minus half an hour)
Secondary Outcome Measure Information:
Title
Blood Pressure
Time Frame
An hour and a half (plus or minus half an hour)
Title
Heart Rate
Time Frame
An hour and a half (plus or minus half an hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Free from any known illness. Between 18 and 40 years of age. Exclusion Criteria: History of heart/respiratory problems Pregnancy Presence of implants, including cardiac pacemakers or orthopaedic implants History of a neurological disorder History of severe arterial disease or known dermatological problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gearoid OLaighin, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Ireland, Galway
City
Galway
Country
Ireland

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow

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