Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,000
- 试验地点
- 16
- 主要终点
- Supplemental Oxygen Free Days (SOFD)
研究概览
简要总结
The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
详细描述
Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) range of 60-100 mmHg (when applicable), and a fraction of inspired oxygen (FiO2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated patients.
Specific Aim: The purpose of this study is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
Hypotheses: Clinical efforts to through a multimodal educational intervention will:
- Improve the proportion of time spent within target normoxemia thresholds (oxygen saturation [SpO2] 90-96% and/or arterial oxygen [PaO2] 60-100 mmHg [when applicable]
- Limit use of excessive supplemental oxygen
- Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acutely injured patients who meet the criteria for entry into the state or national trauma registry
- •Admission to surgical/trauma ICU within 24 hours of hospital arrival
排除标准
- •Age <18 years
- •Prisoners
- •Known pregnancy
- •Transferred patients not admitted through the emergency department
结局指标
主要结局
Supplemental Oxygen Free Days (SOFD)
时间窗: up to 28 days
Number of days alive and not on supplemental oxygen during the index hospitalization (0 days \[worst outcome\] to 28 days \[best outcome\])
次要结局
- Ventilator Free Day (VFD) to day 28(up to 28 days)
- Hospital-Free Days to day 90 (HFD90)(up to 90 days)
- Amount of Supplemental Oxygen Administered(up to 90 days)
- In-hospital Mortality to day 90(up to 90 days)
- Time to Mortality to day 90(up to 90 days)
- Duration of Time receiving High Levels of Supplemental Oxygen(up to 90 days)
- Time to Room Air(up to 90 days)
- Glasgow Outcome Score (GOS)(up to 90 days)
- Discharge Disposition(up to 90 days)
- Duration of Hyperoxemic Event (SpO2>96%)(up to 90 days)
- Duration of Time on Normoxemia Protocol Target(up to 90 days)
- Proportion of Participants Receiving High Levels of Supplemental Oxygen(up to 90 days)
- Incidence of Hypoxemic Event (SpO2<88%)(up to 28 days)
- Duration of Hypoxemic Events (SpO2<88%)(up to 90 days)
- incidence of Hyperoxemic Event (SpO2>96%)(up to 90 days)
- Duration of Time Receiving No Supplemental Oxygen(up to 90 days)