NCT01871909已完成不适用
Validation of LBNP Model of Human Hemorrhage in Trauma Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Approximation accuracy
研究概览
简要总结
Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans. The investigators hypothesize that the physiologic changes that occur with application of LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that LBNP is a truly valid model of human hemorrhage.
详细描述
Specific aims:
- Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.
- Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.
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
- 31 Days 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 31 days - 89 years
- •patients cared for in the Emergency Department (ED), Operating Room (OR), or the Intensive Care Unit (ICU) at Denver Health Medical Center, Children's Hospital Colorado and San Antonio Military Medical Center
- •Patients with report of physical trauma within 24 hours of presentation at the hospital.
排除标准
- •pregnant patients
- •incarcerated patients
- •patients who object at any time to participating in the study
结局指标
主要结局
Approximation accuracy
时间窗: Up to 12 months
Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.
Waveform data comparison
时间窗: Up to 12 months
Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.
次要结局
未报告次要终点
研究者
研究点 (3)
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