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

Study acronym: BREATHE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Enrollment closed, study ongoing Primary completion date: Sep 30, 2026 to Oct 12, 2026 · Site details revised at 5 of 5 sitesv10 Show 2 more changesShow less
    • Primary completion date: Sep 30, 2026 to Oct 12, 2026
    • Site details revised at 5 of 5 sites
  2. Minor Secondary endpoints: 8 to 11v9 See this version in full on ClinicalTrials.gov ↗
  3. Minor Secondary endpoints: details revised at 1 of 8 entriesv8
  4. Minor Secondary endpoints: details revised at 1 of 8 entriesv7
  5. Notable Enrollment target: 1054 to 1600 Primary completion date: Aug 31, 2025 to Sep 30, 2026 · Completion date: Oct 31, 2025 to Dec 31, 2026v6 Show 2 more changesShow less
    • Primary completion date: Aug 31, 2025 to Sep 30, 2026
    • Completion date: Oct 31, 2025 to Dec 31, 2026
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Primary completion date: Dec 31, 2024 to Aug 31, 2025 Completion date: Mar 31, 2025 to Oct 31, 2025v5 Show 1 more changeShow less
    • Completion date: Mar 31, 2025 to Oct 31, 2025
  2. Minor Site details revised at 1 of 5 sitesv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Nov 30, 2024 to Dec 31, 2024 · Completion date: Feb 28, 2025 to Mar 31, 2025 · Start date changed from estimate of Sep 2023 to Oct 11, 2023 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Nov 30, 2024 to Dec 31, 2024
    • Completion date: Feb 28, 2025 to Mar 31, 2025
    • Start date changed from estimate of Sep 2023 to Oct 11, 2023
    • Site details revised at 5 of 5 sites
  4. Notable Start date: Jul 2023 to Sep 2023 Study sites: 0 to 5 · Primary completion date: Oct 2024 to Nov 30, 2024 · Completion date: Jan 2025 to Feb 28, 2025 · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 5
    • Primary completion date: Oct 2024 to Nov 30, 2024
    • Completion date: Jan 2025 to Feb 28, 2025
    • Eligibility criteria expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05754034
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: Wellcome Trust
Conditions Acute Hypoxemia
Enrollment 1,600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov