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
168 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
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.
CONDITIONS
Official 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 site hospital within 24 hours prior to screening
- Blood oxygen saturation (SpO2) below 90% at first assessment or currently receiving oxygen
You will not qualify if you...
- High likelihood of death within 24 hours of admission
- Patient or caregiver refuses to participate
- History of chronic respiratory failure with SpO2 below 90% or oxygen dependence for at least three months
- Anatomical issues preventing nasal cannula use
- Intubation or non-invasive ventilation before screening
- Known hypoxemia at transferring facility for more than 48 hours
- Lack of availability of either standard flow or high flow oxygen devices or supplies at randomization
AI-Screening
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Trial Site Locations
Total: 5 locations
1
AIC Kijabe Hospital
Kijabe, Kenya
Actively Recruiting
2
Nakuru Level V Hospital
Nakuru, Kenya
Actively Recruiting
3
Queen Elizabeth Central Hospital
Blantyre, Malawi
Actively Recruiting
4
The University Teaching Hospital of Butare (CHUB)
Huye, Rwanda
Actively Recruiting
5
The University Teaching Hospital of Kigali (CHUK)
Kigali, Rwanda
Actively Recruiting
Research Team
E
Elisabeth Riviello, MD, MPH
CONTACT
T
Theogene Twagirumugabe, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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