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NCT Number: NCT05754034

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

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.

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Key information

Conditions

Acute Hypoxemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIC Kijabe Hospital, Kijabe, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High flow oxygen

Device

humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%

Standard flow oxygen

Other

oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%

Primary outcomes

  1. In-hospital mortality

    Time frame: Day 90

    Death between randomization and end of hospitalization

Secondary outcomes

  1. 90-day mortality

    Time frame: Day 90

    Death between randomization and 90 days

  2. 90-day functional status

    Time frame: Day 90

    Functional status 90 days after randomization, as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  3. Need for mechanical ventilation

    Time frame: Day 90

    Met criteria for need to escalate respiratory therapy to NIV or invasive ventilation, or escalated to NIV or mechanical ventilation

  4. Days requiring oxygen

    Time frame: Day 90

    Days requiring oxygen from randomization to end of hospitalization

  5. Hospital length of stay

    Time frame: Day 90

    Days from randomization to hospital discharge or death

  6. ICU length of stay

    Time frame: Day 90

    Total days in the ICU during hospitalization

  7. Time to meeting criteria for need for escalation to either NIV or invasive ventilation

    Time frame: Day 90

    Time to meeting clinical criteria for escalation to non-invasive ventilation or invasive ventilation

  8. Time to escalation to either NIV or invasive ventilation

    Time frame: Day 90

    Time to escalation to non-invasive ventilation or invasive ventilation

Other outcomes

  1. Oxygen consumption

    Time frame: Day 90

    Total oxygen consumed during hospitalization

  2. 90-day hospital re-admission

    Time frame: 90 days

    Re-admission to the hospital after discharge and before 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Riviello, MD, MPH

CONTACT

[email protected]

+1 617 447 5131

Theogene Twagirumugabe, MD, PhD

CONTACT

[email protected]

+250 788 539 904

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Wellcome Trust

Registry information

Acronym: BREATHE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.