Comparing high flow oxygen to standard flow oxygen for treating low blood oxygen levels in East Africa
Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
This study is testing if high flow oxygen works better than standard flow oxygen to help adults with low blood oxygen levels in East Africa feel better and stay alive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 5 sites (Kijabe and 4 other locations) |
| Trial ID | NCT05754034 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of high flow oxygen compared to standard flow oxygen in improving outcomes for adult patients with acute hypoxemia in low and middle-income countries. Conducted in five hospitals, it aims to determine if high flow oxygen reduces mortality rates and identifies the challenges and facilitators of its use in these settings. Participants will be randomly assigned to receive either high flow or standard flow oxygen, and the study will also assess the oxygen consumption of each method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to a participating hospital with low blood oxygen levels.
Not a fit: Patients who are imminently dying or have chronic respiratory failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates for patients suffering from acute hypoxemia in resource-limited settings.
How similar studies have performed: While studies in high-income countries have shown potential benefits of high flow oxygen, this approach has not been rigorously tested in low or middle-income countries, making this study novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kijabe and 4 other locations
- AIC Kijabe Hospital — Kijabe, Kenya (Recruiting)
- Nakuru Level V Hospital — Nakuru, Kenya (Recruiting)
- Queen Elizabeth Central Hospital — Blantyre, Malawi (Recruiting)
- The University Teaching Hospital of Butare (CHUB) — Huye, Rwanda (Recruiting)
- The University Teaching Hospital of Kigali (CHUK) — Kigali, Rwanda (Recruiting)
Study contacts
- Principal investigator: Elisabeth Riviello, MD, MPH — Beth Israel Deaconess Medical Center
- Study coordinator: Elisabeth Riviello, MD, MPH
- Email: eriviell@bidmc.harvard.edu
- Phone: +1 617 447 5131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.