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

Not Applicable

Recruiting

• Conditions: Acute Hypoxemia
• Interventions: Device: High flow oxygen; Other: Standard flow oxygen

• Registration Number: NCT05754034
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-03
• Study Start: 2023-10-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1054

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow oxygen	High flow oxygen	Heated and humidified oxygen delivered via high flow oxygen device through nasal cannula, up to 60 liters per minute of flow.
Standard flow oxygen	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.

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	Day 90	Death between randomization and end of hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (5)

The University Teaching Hospital of Butare (CHUB); 🇷🇼 Huye, Rwanda

AIC Kijabe Hospital; 🇰🇪 Kijabe, Kenya

Nakuru Level V Hospital; 🇰🇪 Nakuru, Kenya

Queen Elizabeth Central Hospital; 🇲🇼 Blantyre, Malawi

The University Teaching Hospital of Kigali (CHUK); 🇷🇼 Kigali, Rwanda