Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
NCT ID: NCT05754034
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1600 participants
INTERVENTIONAL
2023-10-11
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High flow oxygen
Heated and humidified oxygen delivered via high flow oxygen device through nasal cannula, up to 60 liters per minute of flow.
High flow oxygen
humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%
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.
Standard flow oxygen
oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%
Interventions
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High flow oxygen
humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%
Standard flow oxygen
oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Wellcome Trust
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Elisabeth Riviello
Assistant Professor of Medicine
Principal Investigators
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Elisabeth Riviello, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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AIC Kijabe Hospital
Kijabe, , Kenya
Nakuru Level V Hospital
Nakuru, , Kenya
Queen Elizabeth Central Hospital
Blantyre, , Malawi
The University Teaching Hospital of Butare (CHUB)
Huye, , Rwanda
The University Teaching Hospital of Kigali (CHUK)
Kigali, , Rwanda
Countries
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Central Contacts
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Facility Contacts
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Nelly Kebeny, RN
Role: primary
Wanja Kageche, RN
Role: primary
Innocent Sulani, MBBS, MSc
Role: primary
Blaise Gahungu, MMed
Role: primary
Dona Fabiola, MMed
Role: primary
Other Identifiers
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222165/Z/20/Z
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022P001102
Identifier Type: -
Identifier Source: org_study_id
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