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:
1. For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality?
2. What are the facilitators and barriers to using high flow oxygen in these settings?
3. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.