Evaluation of an Inspiratory Impedance Threshold Device (ITD) in the Emergency Department for the Treatment of Hypotension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline
研究概览
简要总结
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss, sepsis, or dehydration.
详细描述
The study is designed to test the hypothesis that use of the ITD will result in a rapid rise in blood pressure secondary to an increase in cardiac output. Either an active or sham ITD will be applied to hypotensive patients when initially presented to the emergency department with a systolic blood pressure of <95mmHg. The main endpoint of this study will be the rise in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well as clinical studies performed to date, we hypothesize that use of the active ITD will result in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical parameters will also be compared between the two groups of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conscious patient
- •Systolic blood pressure < 95 mmHg
- •Hypotension caused by blood loss, sepsis, or dehydration
排除标准
- •Hypotension secondary to heart failure
- •Complaints of chest pain
- •History of heart failure
- •Complaints of shortness of breath
结局指标
主要结局
Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline
时间窗: every 2 minutes during 10 minutes of device use
次要结局
- Quantity of Fluid Administration(during 10 minutes of device use)