Acute HypoxemiaBREATHENCT05754034
Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
A study testing High flow oxygen and Standard flow oxygen in people with Acute Hypoxemia, run by Beth Israel Deaconess Medical Center at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemia
- What is being tested?
- High flow oxygen and Standard flow oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 11 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Rwanda2 sites
The University Teaching Hospital of Butare (CHUB)
Huye
The University Teaching Hospital of Kigali (CHUK)
Kigali
About this study
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:
Read more
- 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.
- Conditions
- Acute Hypoxemia
- Being tested
- High flow oxygen, Standard flow oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow oxygenDevice
humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%
Standard flow oxygenOther
oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%
| Study group | Role | What they receive |
|---|---|---|
| High flow oxygen | Experimental | Heated and humidified oxygen delivered via high flow oxygen device through nasal cannula, up to 60 liters per minute of flow. Receives: Device: High flow oxygen |
| Standard flow oxygen | Active comparator | Oxygen delivered via standard oxygen devices at standard flows up to 15 liters per minute: nasal cannula, face mask, or nonrebreather mask. Receives: Other: Standard flow oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death between randomization and end of hospitalization
Measured: Day 90
Secondary outcomes (11)
90-day mortality
Death between randomization and 90 days
Measured: 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)
Measured: Day 90
Need for mechanical ventilation
Met criteria for need to escalate respiratory therapy to NIV or invasive ventilation, or escalated to NIV or mechanical ventilation
Measured: Day 90
Days requiring oxygen
Days requiring oxygen from randomization to end of hospitalization
Measured: Day 90
Hospital length of stay
Days from randomization to hospital discharge or death
Measured: Day 90
ICU length of stay
Total days in the ICU during hospitalization
Measured: Day 90
Time to meeting criteria for need for escalation to either NIV or invasive ventilation
Time to meeting clinical criteria for escalation to non-invasive ventilation or invasive ventilation
Measured: Day 90
Time to escalation to either NIV or invasive ventilation
Time to escalation to non-invasive ventilation or invasive ventilation
Measured: Day 90
Oxygen consumption (rate)
Rate of oxygen used from randomization until hospital discharge.
Measured: Day 90
Oxygen consumption (volume)
Volume of oxygen used from randomization until hospital discharge
Measured: Day 90
90-day hospital readmission
Readmission to the hospital after discharge and within 90 days of randomization
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start11 Oct 2023
- Primary completion12 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute HypoxemiaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Principal investigator, Elisabeth Riviello, Beth Israel Deaconess Medical Center
- Investigators
- Elisabeth Riviello, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754034
- Sponsor's protocol ID
- 2022P001102
- Other IDs
- 222165/Z/20/Z
- Acronym
- BREATHE
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers for the trial overall. IPD is owned and managed by each of the sites for the trial, in accordance with the data protection requirements of each country where the sites are located. Individual sites may decide to share their own IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
- ClinicalTrials.gov ID
- NCT05754034
- Acronym / sponsor ID
- BREATHE / 2022P001102
- Conditions
- Acute Hypoxemia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow oxygen | Experimental | Device: High flow oxygenHeated and humidified oxygen delivered via high flow oxygen device through nasal cannula, up to 60 liters per minute of flow. |
| Standard flow oxygen | Active comparator | Other: Standard flow oxygenOxygen delivered via standard oxygen devices at standard flows up to 15 liters per minute: nasal cannula, face mask, or nonrebreather mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow oxygenhumidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94% | Device | High flow oxygen |
| Standard flow oxygenoxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94% | Other | Standard flow oxygen |
Primary outcome
In-hospital mortality
Time frame: Day 90
Death between randomization and end of hospitalization
11 secondary outcomes
90-day mortality
Time frame: Day 90
90-day functional status
Time frame: Day 90
Need for mechanical ventilation
Time frame: Day 90
Days requiring oxygen
Time frame: Day 90
Hospital length of stay
Time frame: Day 90
ICU length of stay
Time frame: Day 90
Time to meeting criteria for need for escalation to either NIV or invasive ventilation
Time frame: Day 90
Time to escalation to either NIV or invasive ventilation
Time frame: Day 90
Oxygen consumption (rate)
Time frame: Day 90
Oxygen consumption (volume)
Time frame: Day 90
90-day hospital readmission
Time frame: Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers for the trial overall. IPD is owned and managed by each of the sites for the trial, in accordance with the data protection requirements of each country where the sites are located. Individual sites may decide to share their own IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Riviello, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow oxygen and Standard flow oxygen in people with Acute Hypoxemia, run by Beth Israel Deaconess Medical Center at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Kenya, Rwanda, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.