Actively Recruiting
Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
Led by Beth Israel Deaconess Medical Center · Updated on 2026-01-12
1600
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
W
Wellcome Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate oxygen delivery methods for adult patients with acute hypoxemia in resource-limited hospitals in low or lower middle income countries. The study specifically compares high flow oxygen with standard flow oxygen to determine which method leads to lower mortality and better patient outcomes in these settings. It also seeks to identify challenges and facilitators for using high flow oxygen and to measure oxygen consumption differences between the two methods. Participants will be randomly assigned to one of two groups one receiving heated and humidified high flow oxygen delivered via nasal cannula at flows up to 60 liters per minute, and the other receiving standard flow oxygen through nasal cannula, face masks, or non-rebreather masks at flows up to 15 liters per minute. Both groups will follow protocols targeting oxygen saturation levels between 90 and 94. The study will take place in five hospitals and will monitor oxygen use and feasibility factors. During the study, participants will be monitored for in-hospital mortality up to 90 days, functional status, need for mechanical ventilation, duration of oxygen use, and lengths of hospital and ICU stay. Researchers will evaluate the time to any escalation of respiratory support. Data collection will include assessments of oxygen delivery, patient outcomes, and resource use, with the total observation period lasting 90 days after enrollment.
CONDITIONS
Brief Title
Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Admitted to a study hospital within 24 hours before screening
- Oxygen saturation (SpO2) below 90% at first assessment or currently receiving oxygen
You will not qualify if you...
- Expected death within 24 hours of admission
- Patient or caregiver refuses participation
- History of chronic respiratory failure or oxygen dependence for at least three months
- Anatomical issues preventing use of nasal cannula
- Intubation or non-invasive ventilation before screening
- Known hypoxemia at transferring facility for more than 48 hours
- Lack of availability of either high flow or standard flow oxygen devices or supplies at randomization
Research Team
E
Elisabeth Riviello, MD, MPH
T
Theogene Twagirumugabe, MD, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here