Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
- 试验地点
- 12
- 主要终点
- In-hospital mortality
研究概览
简要总结
Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in low or lower middle income countries (LMICs) have not been performed. Studies in sepsis have demonstrated that interventions that improve outcomes in one context may actually be neutral or harmful in a different context.
The goal of this study is to test whether high flow oxygen results in better outcomes for hypoxemic adult patients, as compared with standard flow oxygen, in five LMIC hospitals. The main questions it aims to answer are:
- For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality?
- What are the facilitators and barriers to using high flow oxygen in these settings?
- Does high flow or standard flow oxygen use more oxygen?
Participants will be randomized to receive either high flow oxygen through a large nasal cannula, or to receive standard flow oxygen, through nasal cannulas, face masks, or non-rebreather masks. Researchers will compare the outcomes for the two groups, to see if one group of patients has better outcomes than the other.
The study will also examine how much oxygen is used by the two patient groups, as well as other factors relevant to the feasibility of implementation of high flow oxygen in these sites.
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
- Single (Outcomes Assessor)
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
- •age>=18 years AND
- •admitted to a study site hospital within the 24 hours prior to screening AND
- •SpO2<90% at time of first assessment OR
- •receiving oxygen at time of first assessment
排除标准
- •imminent death (high clinical suspicion of death within 24 hours of admission)
- •patient or caregiver refusal of study participation
- •history of chronic respiratory failure (SpO2<90% or oxygen dependence for at least three months)
- •anatomical factors precluding the use of nasal cannula
- •intubation or non-invasive ventilation by the clinical team prior to screening for the trial
- •known hypoxemia at transferring facility for >48 hours
- •lack of availability of either SFO or HFO devices or supplies at the time of randomization.
研究组 & 干预措施
High flow oxygen
Heated and humidified oxygen delivered via high flow oxygen device through nasal cannula, up to 60 liters per minute of flow.
干预措施: High flow oxygen (Device)
Standard flow oxygen
Oxygen delivered via standard oxygen devices at standard flows up to 15 liters per minute: nasal cannula, face mask, or nonrebreather mask.
干预措施: Standard flow oxygen (Other)
结局指标
主要结局
In-hospital mortality
时间窗: Day 90
Death between randomization and end of hospitalization
次要结局
- 90-day mortality(Day 90)
- Days requiring oxygen(Day 90)
- ICU length of stay(Day 90)
- Time to escalation to either NIV or invasive ventilation(Day 90)
- 90-day functional status(Day 90)
- Hospital length of stay(Day 90)
- Need for mechanical ventilation(Day 90)
- Time to meeting criteria for need for escalation to either NIV or invasive ventilation(Day 90)
- Oxygen consumption (rate)(Day 90)
- Oxygen consumption (volume)(Day 90)
- 90-day hospital readmission(Day 90)
研究者
Elisabeth Riviello
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center