Quantifying the Venous Congestion Curve of a Tissue Oximetry Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Transcutaneous Oximetry (StO2) of Vascular Occlusion Test at 0.5 Hours
研究概览
简要总结
The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox.
ViOptix probes will be secured to the arm and hand. The recording process on the ViOptix machine will begin and obtain baseline StO2 levels for 5 minutes. After 5 minutes, a blood pressure cuff will be inflated on one arm. This blood pressure cuff will be left inflated for 10-20 minutes. Every 2 minutes a pulse check or doppler exam will be performed at your wrist. Last, the cuff will be deflated and the you will be free to leave the study room.
详细描述
The rate of decline and pattern seen in tissue oxygenation as quantified by a NIRS device (ViOptiox T.Ox) can be quantified and described by a mathematical model which will allow earlier detection and identification of venous congestion in tissue. The vascular occlusion test has been established as a safe and accurate model to induce various states of vascular insufficiency and occlusion. Specifically the vascular occlusion test has been demonstrated to be an accurate model for inducing venous insufficiency on awake and aware patients. This study will aim to analyze the StO2 data output of the ViOptix in order to establish the earliest signs of tissue failure in various states of vascular compromise.
The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox. The data collected will be used to formulate a mathematical model which will allow earlier detection and identification of venous congestion in tissue. Identifying these specific patterns will help to establish an evidence-based approach in recognizing specific problems and patterns associated with tissue compromise that can guide physicians to consider earlier flap salvage measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age 18 - 65 volunteers
排除标准
- •Subjects with a history of major cardiac disease, peripheral vascular disease including (vascular insufficiency), Raynaud syndrome, blood dyscrasias, pain syndromes, neurologic conditions, major upper extremity soft tissue trauma or previous vascular injury
结局指标
主要结局
Transcutaneous Oximetry (StO2) of Vascular Occlusion Test at 0.5 Hours
时间窗: Hour 0.5
transcutaneous oximetry (StO2) of vascular occlusion test at 0.5 hours - an StO2 greater than 55 mmHg is considered normal regardless of the site of measurement
次要结局
未报告次要终点
