None listed
Conditions
Brief summary
There is a device called an Intermittent Pneumatic Compression (IPC) device, that may be used to improve blood flow in the legs of patients when they have had operations or been admitted to hospital. IPCs have been shown to reduce the risk of developing blood clots in the legs (Deep Vein Thrombosis – DVT) and the lungs (Pulmonary Embolism – PE) due to long periods of immobility. They work by placing an inflatable cuff on the patients’ calf or foot, which is then inflated several times a minute while the patient is immobilized. The inflated cuff squeezes the veins in the sole of the foot and the calf, reducing pooling of blood in the leg, and thus reducing the risk of blood clots forming in the veins. We want to see whether the fibreglass cast impairs the performance of the IPC underneath it. To figure this out, we want to measure the return of blood from the legs in study participants who have an IPC device on both feet, and who then have one leg placed in a fibreglass cast.
Interventions
An Intermittent Pneumatic Compression System (IPCS), VENA PRESS System with foot garment. (Website photos and description of features: http://priushcs.com/?page_id=159) will be placed on both feet of healthy volunteers. This is a system that is used regularly for DVT prophylaxis in high risk and immobile patients post-surgery.
The subjects' feet will be placed in a foot compression garment (a cuff) that will be attached by tube assembly to a pump unit. When the pump unit is turned on, a distal
An Intermittent Pneumatic Compression System (IPCS), VENA PRESS System with foot garment. (Website photos and description of features: http://priushcs.com/?page_id=159) will be placed on both feet of healthy volunteers. This is a system that is used regularly for DVT prophylaxis in high risk and immobile patients post-surgery. The subjects' feet will be placed in a foot compression garment (a cuff) that will be attached by tube assembly to a pump unit. When the pump unit is turned on, a distal aircell within the foot cuff will inflate rapidly to approximately 130mmHg +/-10% and will then settle to 52mmHg, and a proximal aircell follows approximately 0.3 seconds after, to settle at approximately 48mmHg. After 6 seconds of compression at 48-53mmHg, the cuffs deflate. The cycle repeats every minute Volunteers will then be randomised to have either their left or right foot (and the compression garment) placed within a below knee fibreglass cast, as would normally be placed if someone suffered a fractured ankle or an Achilles tendon rupture. Ultrasound (USS) measurements of bilateral popliteal vein blood flow will be done to compare the performance of the IPC device within a fibreglass cast to the performnace outside of a fibreglass cast. Measurements will be done at the following times (All USS measures will be done on the left leg first, regardless of which is randomised to the cast, and will be undertaken twice for each measure – the mean of both measures will be used for statistical analysis). - Baseline (Time 0) - 40 minutes: prior to starting the IPC device - 60 minutes: after the IPC device has been running for 10 minutes continuously After obtaining the final measure at 60 minutes, the study will be deemed to have been completed. At the end of the study the cast and IPC devices will be removed.
Sponsors
Medical Research Institiute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
- Aged between 18 to 65 years - Able to provide informed consent
Exclusion criteria
1. History of previous or current deep vein thrombosis 2. Pregnancy (this may alter lower limb venous return from compression at the level of the iliac vein) 3. Any hyper-coagulable disorders including history of cancer other than basal cell carcinoma of the skin, non-invasive basal cell carcinoma of the skin 4. History or clinical features of peripheral vascular disease (including arterial and venous insufficiency), or other lower limb abnormalities, such as peripheral neuropathy, scleroderma, lymphoedema, or joint deformity from inflammatory arthritis 5. Abnormal clinical examination of the lower limbs, which may indicate one of the above mentioned exclusion medical conditions. (i.e. such as the presence of ischemic ulceration)
Outcome results
None listed