Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction With Intermittent Pneumatic Compression.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Mayo Dopplex ABllity device Venous hemodynamic pressure
研究概览
简要总结
The purpose of this research is to measure changes in venous blood flow with an air-filled bladder under an intermittent pneumatic compression device cuff (used to prevent deep venous thrombosis) or venous diagnostic device cuff (used to detect deep venous thrombosis). The devices being used in the study are investigational and not FDA-cleared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Venous ultrasound study to evaluate for lower extremity DVT unilateral and/or bilateral within previous 72 hours.
排除标准
- •Patients with inaccessible target limb (ultrasound limb) due to bandages (wound, burn, lesion, etc) or cast.
- •Patients with leg trauma, fracture, above or below knee amputation, or other condition in which compressing on the calf is medically inappropriate or not possible.
- •Patients unable to provide informed written consent.
结局指标
主要结局
Mayo Dopplex ABllity device Venous hemodynamic pressure
时间窗: Baseline
Venous hemodynamic pressure to be measured from both the recumbent and sitting positions using the Mayo Dopplex ABllity device. Measured as mmHg.
Intermittent Pneumatic Compression device Venous hemodynamic pressure
时间窗: Baseline
Venous hemodynamic pressure to be measured from both the recumbent and sitting positions using the IPC device. Measured as mmHg.
次要结局
未报告次要终点
研究者
Damon E. Houghton
Physician, Vascular Medicine
Mayo Clinic