Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Wellell Inc. Taiwan
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Peak Velocity of Blood Flow Increasement
Overview
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:
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- All
- Accepts 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
- •Dermatitis, gangrene, or severe wounds
- •Massive edema of legs
- •Pregnancy
- •Pulmonary edema
Outcomes
Primary Outcomes
Peak Velocity of Blood Flow Increasement
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported