Intermittent Pneumatic Compression
Conditions
Keywords
neuromuscular stimulation, intermittent pneumatic compression
Brief summary
What is known? * Disorders of peripheral circulation result in vascular morbidity and mortality * Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease * The benefit of intermittent pneumatic compression is clinically well evidenced. * The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source. What new information will this trial contribute? \- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation
Detailed description
RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease. OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects. METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.
Interventions
DEVICENeuromuscular stimulation, followed by intermittent pneumatic compression
DEVICEIntermittent pneumatic compression, followed by neuromuscular stimulation
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Age \>18 yrs, Body Mass Index (BMI) 17-30Kg/m2
Exclusion criteria
History of heart disease or respiratory disorder, pregnancy, history of peripheral vascular disease or previous thromboembolic event, ABPI\< 0.9, cardiac pacemaker, history of leg fractures and/or presence of metal implants in the leg, long distance travel within one week prior to study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPC(on) Peak Velocity Change From Baseline | One day | Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery |
Other
| Measure | Time frame |
|---|---|
| NMES(on) Peak Velocity Change From Baseline | One day |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Half of recruited subjects (n=5)
Neuromuscular stimulator followed by IPC | 5 |
| Group 2 Other half of recruited subjects (n=5)
IPC followed by neuromuscular stimulator | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 27.1 years STANDARD_DEVIATION 3.8 | 27.1 years STANDARD_DEVIATION 3.8 | 27.1 years STANDARD_DEVIATION 3.8 |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
IPC(on) Peak Velocity Change From Baseline
Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery
Time frame: One day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Summation | IPC(on) Peak Velocity Change From Baseline | 6.2 cm/s |
Other Pre-specified
NMES(on) Peak Velocity Change From Baseline
Time frame: One day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Summation | NMES(on) Peak Velocity Change From Baseline | 36.7 cm/s |