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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foot IPC | Active Comparator | Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA |
|
| Rapid calf IPC | Active Comparator | Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA |
|
| Slow calf IPC | Active Comparator | Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA |
|
| Calf NMES | Active Comparator | Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot IPC | Device | Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Flow - Peak Systolic Velocity (cm/Sec) | With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein. | up to one hour in total |
| 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. | up to one hour in total |
| Blood Flow - Volume Flow (ml/Min) | With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein. | up to one hour in total |
| 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. | up to one hour in total |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemodynamic Studies | Patients undergoing different interventions to promote venous return. Washout (1 hour) in between different interventions. Patients started in different orders with: "Foot IPC", "Rapid Calf IPC", "Slow Calf IPC" and "Calf NMES". |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemodynamic Studies | Patients undergoing different stimulations of venous blood flow. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | cm/s | up to one hour in total |
|
8 hours during the baseline and intervention assessments.
The interventions were performed sequentially on each participant after baseline, in total 10 participants.
One patient did not perform the Rapid calf IPC intervention. Adverse events were registered during and after the application of these interventions.
Specifically assessments of pain were made during the application of each intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foot IPC | Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Pain | Systematic Assessment | Pain in the limb with cramping sensation when applying NMES. Comfortability scale (0-10). When patients scored 4 or less. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Ackermann | Karolinska University Hospital | +46 8 517 700 00 | 717 34 | paul.ackermann@sll.se |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Rapid calf IPC | Device | Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA |
|
|
| Slow calf IPC | Device | Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA |
|
|
| Calf NMES | Device | Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator |
|
|
| one minute |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Rapid Calf IPC | Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA |
| OG003 | Slow Calf IPC | Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA |
| OG004 | Calf NMES | Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator |
|
|
| 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. | Posted | Mean | Standard Deviation | cm/s | up to one hour in total |
|
|
|
| Primary | Blood Flow - Volume Flow (ml/Min) | With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein. | Posted | Median | Standard Deviation | ml/min | up to one hour in total |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ml | up to one hour in total |
|
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | units on a scale | one minute |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Rapid Calf IPC | Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Slow Calf IPC | Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Calf NMES | Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator | 0 | 10 | 0 | 10 | 7 | 10 |
|
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |