- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01886612
A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow
A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Galway, Ireland
- National University of Ireland, Galway
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DVT Prophylaxis
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. |
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Flow Measurements from the Lower Limb
Time Frame: An hour and a half (plus or minus half an hour)
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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
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An hour and a half (plus or minus half an hour)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Pressure
Time Frame: An hour and a half (plus or minus half an hour)
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An hour and a half (plus or minus half an hour)
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Heart Rate
Time Frame: An hour and a half (plus or minus half an hour)
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An hour and a half (plus or minus half an hour)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EE-NMES-DVT-333
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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