Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 572
- 试验地点
- 1
- 主要终点
- Patient-time Hyperoxic and Not on Room Air
研究概览
简要总结
The objective of this study is to conduct an observational pre/post study to evaluate the clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in critically ill trauma patients.
详细描述
Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance of hypoxia is vital, the current clinical practice of excessive oxygenation settings is common, and unnecessary, and may even be harmful.
An expert panel convened to define optimal oxygenation targets in critically ill trauma patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of 90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial implementation of this consensus will occur for the care of trauma patients.
Specific Aim:
This is an observational pre/post study to evaluate the impact of targeted normoxia implementation in optimizing oxygen delivery and oxygenation in critically ill trauma patients.
Hypotheses:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 109 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Injury/Trauma
- •Arrival to Emergency Department
排除标准
- •<18 years of age
- •Known prisoners
结局指标
主要结局
Patient-time Hyperoxic and Not on Room Air
时间窗: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days from dates Jan. 1, 2018 to July 1, 2019
Total percentage of patient-time hyperoxic and not on room air: total time spent by patients in a hyperoxic state while receiving supplemental oxygen, divided by total patient time on study
次要结局
- Time to Room Air(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days)
- Measured by Daily Sequential Organ Failure Assessment (SOFA)(First 7 days of hospitalization)
- ICU Length of Stay(From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days)
- Episodes of Hypoxia (SpO2< 88%)(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days)
- Episodes of Hyperoxia (SpO2 >96%)(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days)
- Ventilator Free Day(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days)
- Hospital Length of Stay(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days)
- Hospital Discharge Disposition(Date of hospital discharge, assessed up to 180 days)
- Hospital Mortality(From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days)