No Condition, Healthy Individuals, No Conditions, Aged 20-64
Conditions
Keywords
Intermittent pneumatic compression, Hemodynamics, Venous thromboembolism prophylaxis
Brief summary
The goal of this clinical trial is to learn an Intermittent Pneumatic Compression Device (IPCD), VenAir, effectiveness in healthy adults. The main questions this research aims to answer are: 1. The hemodynamic performance of VenAir paired with the thigh garments, calf garments, and foot garments is not inferior to that of SCD700 paired with the corresponding garments. 2. The hemodynamic performance of VenAir paired with the thigh garments, calf garments, and foot garments is not inferior to that of SCD700 paired with the thigh garment. Researchers will compare VenAir and the SCD700 to see if the hemodynamic performance of VenAir is as well as or not worse than the SCD700. Participants will lie down and rest for approximately 30 minutes to stabilize their heart rate. The researcher will then use ultrasound to measure the participant's blood flow while they wear different leg garments (one at a time) and also when no garment is worn.
Interventions
DEVICEVenAir
VenAir is an intermittent pneumatic compression (IPC) device intended to help prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In this study, VenAir is applied to the participant's lower limb under standard operating settings, and hemodynamic performance is measured for comparison with SCD700.
DEVICESCD700
SCD700 is a commercially available intermittent pneumatic compression (IPC) device used to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In this study, SCD700 is applied to the participant's lower limb under standard operating settings, and hemodynamic performance is measured to compare with VenAir.
Sponsors
Wellell Inc. Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
This study uses a randomized crossover design in which each participant will be tested with two devices (VenAir and SCD700). The same participant will use both devices, allowing each participant to serve as their own control.
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults * Aged 20-64 years * Leg circumference within the size range of the SCD700 and VenAir garments
Exclusion criteria
* Cardiovascular-related diseases (mild atherosclerosis, other ischemic vascular diseases, congestive heart failure, etc.) * Previous suspicion of deep vein thrombosis, pulmonary embolism, or phlebitis * History of stroke * History of varicose vein surgery * Hypertension * Diabetes * Dermatitis, gangrene, or severe wounds * Massive edema of legs * Pregnancy * Pulmonary edema
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Velocity of Blood Flow Increasement | During and immediately after device application | The peak velocity increasement is measured to understand the degree of change in peak blood flow velocity with and without using the IPC device. Baseline peak velocity is calculated by averaging the two highest peaks over a 16-second period without the device. Intervention peak velocity is obtained by averaging the peak velocities over four compression cycles while wearing the IPC device. |
Countries
Taiwan
Contacts
Primary ContactCheng Yung Chang
Outcome results
None listed