Assessment of the Implementation of the ResQGARD® Impedance Threshold Device by the San Antonio Fire Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Change in Systolic Blood Pressure From Baseline (Before ITD Use)
研究概览
简要总结
This study is attached to a comprehensive quality assurance/quality improvement (QA/QI) program conducted by the Office of the medical director, and is designed to contribute to generalizable knowledge to determine effectiveness and tolerability of an FDA approved Impedance Threshold Device (ITD) device in a large urban emergency medical service (EMS) system. The cohort will comprise a convenience sample of patients that are being treated by EMS for a hypotensive emergency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •adults between the ages of 18-120 years
- •presenting to EMS with or development of Hypotension during EMS interaction
- •treated by EMS with the ITD
排除标准
- •pediatric patients
- •patients that do not present with or develop hypotension
- •patients who the ITD will not form a secure seal due to anatomical abnormalities
结局指标
主要结局
Change in Systolic Blood Pressure From Baseline (Before ITD Use)
时间窗: During device use, up to 1 hour
Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.
次要结局
- Tolerability(Duration of device use, up to 1 hour)