Venous ThrombosisNCT01886612
A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow
A study testing Duo-STIM 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 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Duo-STIM 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
- Jun 2013to Aug 2013
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free from any known illness.
- Between 18 and 40 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
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.
- Conditions
- Venous Thrombosis
- Being tested
- Duo-STIM 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.
Duo-STIM 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 (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. Receives: Device: Duo-STIM 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 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
Measured: An hour and a half (plus or minus half an hour)
Secondary outcomes (2)
Blood Pressure
Measured: An hour and a half (plus or minus half an hour)
Heart Rate
Measured: An hour and a half (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 posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
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
- NCT01886612
- Sponsor's protocol ID
- EE-NMES-DVT-333
- Status last verified
- Aug 2013
- First submitted
- 21 Jun 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Haemodynamics
- ClinicalTrials.gov ID
- NCT01886612
- Acronym / sponsor ID
- EE-NMES-DVT-333
- 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
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Jun 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.
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 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: Duo-STIM neuromuscular electrical stimulator, Device: AV Impulse System Model 6000Neuromuscular 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Free from any known illness.
- Between 18 and 40 years of age.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Duo-STIM 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: An hour and a half (plus or minus half an hour)
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
2 secondary outcomes
Blood Pressure
Time frame: An hour and a half (plus or minus half an hour)
Heart Rate
Time frame: An hour and a half (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 2 Aug 2013.
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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 Duo-STIM 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 2 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 2 Aug 2013. 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: An hour and a half (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 2 Aug 2013.