Venous ThrombosisNCT01894997
A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Blood Flow in the Lower Limb
A study testing Neuromuscular electrical stimulator and AV Impulse System Model 6000 in people with Venous Thrombosis, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Neuromuscular electrical stimulator and AV Impulse System Model 6000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2014to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Free from any known illness
- Between 18 and 40 years of age
- Between 55 and 65 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Thrombosis
- Being tested
- Neuromuscular electrical stimulator, AV Impulse System Model 6000
- Keywords
- Deep Vein Thrombosis, Neuromuscular Electrical Stimulation, Intermittent Pneumatic Compression, Doppler Ultrasound
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulatorDevice
AV Impulse System Model 6000Device
Also called Intermittent Pneumatic Compression Device
| Study group | Role | What they receive |
|---|---|---|
| DVT Prophylaxis | Experimental | 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. Receives: Device: Neuromuscular electrical stimulator; Device: AV Impulse System Model 6000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow measurements from the lower limb
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.
Measured: Two hours (plus or minus half an hour)
Secondary outcomes (2)
Blood pressure
Blood pressure will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.
Measured: Two hours (plus or minus half an hour)
Heart rate
Heart rate will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.
Measured: Two hours (plus or minus half an hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Research Council, Galway Clinic
- Responsible party
- Principal investigator, Gearoid O Laighin, National University of Ireland, Galway, Ireland
- Investigators
- Gearoid OLaighin, PhD, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894997
- Sponsor's protocol ID
- EE-NMES-DVT-334
- Status last verified
- Sep 2014
- First submitted
- 3 Jul 2013
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Lower Limb Haemodynamics
- ClinicalTrials.gov ID
- NCT01894997
- Acronym / sponsor ID
- EE-NMES-DVT-334
- Conditions
- Venous Thrombosis
- Keywords
- Deep Vein Thrombosis, Neuromuscular Electrical Stimulation, Intermittent Pneumatic Compression, Doppler Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Irish Research Council, Galway Clinic
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DVT Prophylaxis | Experimental | Device: Neuromuscular electrical stimulator, Device: AV Impulse System Model 6000Neuromuscular 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Free from any known illness
- Between 18 and 40 years of age
- Between 55 and 65 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulator | Device | DVT Prophylaxis |
| AV Impulse System Model 6000Also: Intermittent Pneumatic Compression Device | Device | DVT Prophylaxis |
Primary outcome
Blood flow measurements from the lower limb
Time frame: Two hours (plus or minus half an hour)
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.
2 secondary outcomes
Blood pressure
Time frame: Two hours (plus or minus half an hour)
Heart rate
Time frame: Two hours (plus or minus half an hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gearoid OLaighin, PhD principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulator and AV Impulse System Model 6000 in people with Venous Thrombosis, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow measurements from the lower limb (time frame: Two hours (plus or minus half an hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.