Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation

Study Overview
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Brief Summary
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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: For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality? What are the facilitators and barriers to using high flow oxygen in these settings? 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.

Official Title
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Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation

Conditions
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Acute Hypoxemia

Intervention / Treatment
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* Device: High flow oxygen
* Other: Standard flow oxygen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flow oxygen<br>Heated and humidified oxygen delivered via high flow oxygen device through nasal cannula, up to 60 liters per minute of flow. | Device: High flow oxygen<br>* humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%<br>|
| Active Comparator: Standard flow oxygen<br>Oxygen delivered via standard oxygen devices at standard flows up to 15 liters per minute: nasal cannula, face mask, or nonrebreather mask. | Other: Standard flow oxygen<br>* oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Death between randomization and end of hospitalization | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day mortality | Death between randomization and 90 days | Day 90 | 
| 90-day functional status | Functional status 90 days after randomization, as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | Day 90 | 
| Need for mechanical ventilation | Met objective criteria for need to escalate respiratory therapy to NIV or invasive ventilation, or escalated to NIV or mechanical ventilation | Day 90 | 
| Days requiring oxygen | Days requiring oxygen from randomization to end of hospitalization | Day 90 | 
| Hospital length of stay | Days from randomization to hospital discharge or death | Day 90 | 
| ICU length of stay | Total days in the ICU during hospitalization | Day 90 | 
| Time to meeting criteria for need for escalation to either NIV or invasive ventilation | Time to meeting objective clinical criteria for escalation to non-invasive ventilation or invasive ventilation | Day 90 | 
| Time to escalation to either NIV or invasive ventilation | Time to escalation to non-invasive ventilation or invasive ventilation | Day 90 |