Deep Vein Thrombosis, Venous Stasis
Conditions
Keywords
Intermittent Pneumatic Compression Devices, Electric Stimulation Therapy, Blood Flow Velocity, Hemodynamics
Brief summary
In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities in order to identify those which most effective than the others.
Detailed description
Three Intermittent Pneumatic Compression (IPC) devices were selected: Foot-IPC, rapid Calf-IPC and a slow, sequential Calf-IPC. A Neuromuscular Electrical Stimulation (NMES) device was also used in the calf. Blood flow measurements in the right popliteal vein of ten healthy individuals were performed using Doppler ultrasound before (control) and while using IPC or NMES. The blood flow parameters measured where: peak systolic velocity (cm/s), time-averaged mean velocity (cm/sec), volume flow (ml/min) and ejected volume per individual stimulus (ml). The tolerability of each device was also assessed using an analogue scale from zero to ten. Differences between modalities regarding the pattern as well as the absolute values of velocity and volume are being assessed. Power calculation: Recent studies showed that the peak venous velocity (PV) at baseline is around 11 cm/s and after applying foot-IPC the PV rises to 50 cm/s with a maximum standard deviation of 15 (Broderick et all, 2014). Thus, three patients per group would be required to detect a difference of 39 cm/s in PV (two-sided type-I error rate = 5%; power = 80%). To reach an even higher power we choose to include 10 patients in study, which resulted in a power of 99.7% for the above calculation.
Interventions
DEVICEFoot IPC
Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
DEVICERapid calf IPC
Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
DEVICESlow calf IPC
Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
DEVICECalf NMES
Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Sponsors
Karolinska University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers
Exclusion criteria
* pregnancy * previous lower limb operation involving the vascular system * current thromboprophylactic or thrombolytic therapy * vascular abnormalities in the lower limbs * cardiorespiratory or renal failure causing pitting oedema
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Flow - Peak Systolic Velocity (cm/Sec) | up to one hour in total | With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein. |
| Blood Flow - Time-averaged Mean Velocity (cm/Sec) | up to one hour in total | With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein. |
| Blood Flow - Volume Flow (ml/Min) | up to one hour in total | With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein. |
| Blood Flow - Ejected Volume Per Individual Stimulus (ml) | up to one hour in total | With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability to IPC and NMES According to Visual Analogue Scale 0-10 | one minute | All subjects will be asked to subjectively grade each modality according to how comfortable or uncomfortable it felt under the time was applied to the subject according to Visual Analogue Scale 0-10. The following description will be given to the subjects: 0 denotes the the modality was totally intolerable, 10 denotes that the modality is very pleasant to use and 5 denotes neither pleasant nor unpleasant feeling. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hemodynamic Studies Patients undergoing different stimulations of venous blood flow. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Hemodynamic Studies | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Age, Continuous | 39.7 years STANDARD_DEVIATION 10.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 10 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 9 | 0 / 10 | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Blood Flow - Ejected Volume Per Individual Stimulus (ml)
With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.
Time frame: up to one hour in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Blood Flow - Ejected Volume Per Individual Stimulus (ml) | 5.5 ml | Standard Deviation 3.96 |
| Foot IPC | Blood Flow - Ejected Volume Per Individual Stimulus (ml) | 9.4 ml | Standard Deviation 4 |
| Rapid Calf IPC | Blood Flow - Ejected Volume Per Individual Stimulus (ml) | 19.8 ml | Standard Deviation 8.6 |
| Slow Calf IPC | Blood Flow - Ejected Volume Per Individual Stimulus (ml) | 60.8 ml | Standard Deviation 22.2 |
| Calf NMES | Blood Flow - Ejected Volume Per Individual Stimulus (ml) | 13.6 ml | Standard Deviation 5.9 |
Primary
Blood Flow - Peak Systolic Velocity (cm/Sec)
With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.
Time frame: up to one hour in total
Population: The interventions were performed sequentially on each participant as listed after baseline, in total 10 participants.~One patient did not perform the Rapid calf IPC intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Blood Flow - Peak Systolic Velocity (cm/Sec) | 14.1 cm/s | Standard Deviation 3.42 |
| Foot IPC | Blood Flow - Peak Systolic Velocity (cm/Sec) | 29.5 cm/s | Standard Deviation 8.4 |
| Rapid Calf IPC | Blood Flow - Peak Systolic Velocity (cm/Sec) | 161.6 cm/s | Standard Deviation 47.8 |
| Slow Calf IPC | Blood Flow - Peak Systolic Velocity (cm/Sec) | 39.0 cm/s | Standard Deviation 12.5 |
| Calf NMES | Blood Flow - Peak Systolic Velocity (cm/Sec) | 42.1 cm/s | Standard Deviation 14.9 |
Primary
Blood Flow - Time-averaged Mean Velocity (cm/Sec)
With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.
Time frame: up to one hour in total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Blood Flow - Time-averaged Mean Velocity (cm/Sec) | 4.58 cm/s | Standard Deviation 1.18 |
| Foot IPC | Blood Flow - Time-averaged Mean Velocity (cm/Sec) | 6.53 cm/s | Standard Deviation 1.29 |
| Rapid Calf IPC | Blood Flow - Time-averaged Mean Velocity (cm/Sec) | 13.24 cm/s | Standard Deviation 6.35 |
| Slow Calf IPC | Blood Flow - Time-averaged Mean Velocity (cm/Sec) | 7.12 cm/s | Standard Deviation 1.33 |
| Calf NMES | Blood Flow - Time-averaged Mean Velocity (cm/Sec) | 9.18 cm/s | Standard Deviation 2.3 |
Primary
Blood Flow - Volume Flow (ml/Min)
With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.
Time frame: up to one hour in total
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Baseline | Blood Flow - Volume Flow (ml/Min) | 219 ml/min | Standard Deviation 104 |
| Foot IPC | Blood Flow - Volume Flow (ml/Min) | 309 ml/min | Standard Deviation 132 |
| Rapid Calf IPC | Blood Flow - Volume Flow (ml/Min) | 604 ml/min | Standard Deviation 303 |
| Slow Calf IPC | Blood Flow - Volume Flow (ml/Min) | 345 ml/min | Standard Deviation 124 |
| Calf NMES | Blood Flow - Volume Flow (ml/Min) | 410 ml/min | Standard Deviation 184 |
Secondary
Tolerability to IPC and NMES According to Visual Analogue Scale 0-10
All subjects will be asked to subjectively grade each modality according to how comfortable or uncomfortable it felt under the time was applied to the subject according to Visual Analogue Scale 0-10. The following description will be given to the subjects: 0 denotes the the modality was totally intolerable, 10 denotes that the modality is very pleasant to use and 5 denotes neither pleasant nor unpleasant feeling.
Time frame: one minute
Population: The interventions were performed sequentially on each participant as listed after baseline, in total 10 participants.~One patient did not perform the Rapid calf IPC intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Tolerability to IPC and NMES According to Visual Analogue Scale 0-10 | 6.13 units on a scale | Standard Deviation 1.36 |
| Foot IPC | Tolerability to IPC and NMES According to Visual Analogue Scale 0-10 | 6.3 units on a scale | Standard Deviation 1.17 |
| Rapid Calf IPC | Tolerability to IPC and NMES According to Visual Analogue Scale 0-10 | 8.0 units on a scale | Standard Deviation 1.07 |
| Slow Calf IPC | Tolerability to IPC and NMES According to Visual Analogue Scale 0-10 | 3.3 units on a scale | Standard Deviation 1.67 |