Vasculaire Compression System Increases Flow Velocity in the Femoral Vein
The objective of this clinical study was to demonstrate the performance of the Vasculaire Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This study was a single-arm, open label, prospective, single-center clinical study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluation of the Effect of the Vasculaire Compression System on Flow Velocity in the Femoral Vein|
- Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline [ Time Frame: 3 measurements/10 min. therapy ] [ Designated as safety issue: No ]The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.
- PFV Percent Augmentation [ Time Frame: 3 measurements/10 minute therapy ] [ Designated as safety issue: No ]Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.
- Subject Comfort [ Time Frame: 10 min therapy ] [ Designated as safety issue: No ]Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.
|Study Start Date:||August 2010|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Device: Pneumatic Compression therapy
- Intermittent pneumatic compression
- Sequential compression
Venous thromboembolism, e.g. deep vein thrombosis (DVT) and pulmonary embolism, occurs in approximately one in 1,000 persons in the United States annually and results in more than 250,000 hospital admissions annually in the United States. Intermittent pneumatic compression (IPC), which prevents stasis in the lower limbs, has been shown to be a safe and effective method of prophylaxis of DVT in studies comparing the incidence of DVT and pulmonary embolism with and without IPC. IPC devices decrease venous stasis by augmenting the venous blood flow in the lower extremities. Studies have suggested that an important indicator of the effectiveness of an IPC device in preventing DVT is the peak femoral venous velocity augmentation during the compression phase as compared with the decompression phase of the device.
IPC devices produced in the early 1980s and 1990s were cumbersome, noisy and required external power sources, making them suitable only for non-ambulatory patients. Furthermore, these devices have been associated with poor compliance in trauma patients in a hospital setting, and the poor compliance was associated with a higher rate of DVT.
The aim of this study is to test the hemodynamic performance of a new portable IPC device, the Venous Health Systems' Vasculaire Compression System. This new device is designed to provide patient comfort and convenience of use while providing similar improvement in venous blood flow when compared with existing IPC devices.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240330
|United States, California|
|Venous Health System, Inc.|
|Portola Valley, California, United States, 94028|
|Principal Investigator:||Thomas J Fogarty, M.D.||Founder|