Evaluation of the Effect of the Vasculaire Compression System on Flow Velocity in the Femoral Vein
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between 18 years old and 65 years old;
- •Capable of and willing to lay supine for approximately one hour;
- •Subjects must provide written informed consent
排除标准
- •History of Deep Vein Thrombosis (DVT) or suspected DVT;
- •History of vascular disease, e.g. coronary or peripheral artery disease;
- •History of stroke;
- •History of pulmonary edema;
- •History of congestive heart failure;
- •Diabetes mellitus;
- •Past or present smoker;
- •Surgery or trauma to the right leg within the last six months;
- •Open ulcers or wounds on the right leg;
- •Pregnant or breastfeeding.
结局指标
主要结局
Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline
时间窗: 3 measurements/10 min. therapy
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.
次要结局
- PFV Percent Augmentation(3 measurements/10 minute therapy)
- Subject Comfort(10 min therapy)