A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peak Venous Velocity
研究概览
简要总结
We are comparing two pneumatic compression devices, VenaFlow (stationary) and MCS (portable) in both the supine an standing position. We will start supine and will take 3 baseline measurements of venous velocity and then apply a device and take 3 measurements of the increase in peak venous velocity. We will repeat this with the second device. We will then have the subject stand and repeat the above with each device. We will randomize the order of the devices in the supine and standing position. This study will involve 10 healthy subjects of various ages and 10 total hip replacements (THR) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Phase one: 10 healthy test subjects will be included of various ages. They will have each pneumatic compression device applied in the supine and then standing positions.
- •Phase two: 10 patients following THR on postoperative day #2 will be included. These patients will agree to participate in the study and have to be able to stand for approximately 10 minutes.
排除标准
- •Patients with lymphedema
- •Patients with peripheral vascular disease (chronic venous insufficiency)
- •Patients who do not wish to participate
研究组 & 干预措施
10 Healthy Patients without THA
The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.
干预措施: VenaFlow Elite Supine (Device)
10 Healthy Patients without THA
The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.
干预措施: ActiveCare+SFT Standing (Device)
10 Healthy Patients without THA
The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.
干预措施: VenaFlow Elite Standing (Device)
10 Healthy Patients without THA
The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.
干预措施: ActiveCare+SFT Supine (Device)
10 Patients with THA on Post-Op Day 2
The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.
干预措施: ActiveCare+SFT Supine (Device)
10 Patients with THA on Post-Op Day 2
The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.
干预措施: VenaFlow Elite Supine (Device)
10 Patients with THA on Post-Op Day 2
The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.
干预措施: ActiveCare+SFT Standing (Device)
10 Patients with THA on Post-Op Day 2
The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.
干预措施: VenaFlow Elite Standing (Device)
结局指标
主要结局
Peak Venous Velocity
时间窗: Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied
Ultrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded.
次要结局
未报告次要终点