An interventional study of High flow oxygen and Standard flow oxygen in Acute Hypoxemia, sponsored by Beth Israel Deaconess Medical Center. Active, not recruiting at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
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:
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%
oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%
In-hospital mortality
Death between randomization and end of hospitalization
Time frame: Day 90
90-day mortality
Death between randomization and 90 days
Time frame: 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)
Time frame: 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
Time frame: Day 90
Days requiring oxygen
Days requiring oxygen from randomization to end of hospitalization
Time frame: Day 90
Hospital length of stay
Days from randomization to hospital discharge or death
Time frame: Day 90
ICU length of stay
Total days in the ICU during hospitalization
Time frame: 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
Time frame: Day 90
Time to escalation to either NIV or invasive ventilation
Time to escalation to non-invasive ventilation or invasive ventilation
Time frame: Day 90
Oxygen consumption (rate)
Rate of oxygen used from randomization until hospital discharge.
Time frame: Day 90
Oxygen consumption (volume)
Volume of oxygen used from randomization until hospital discharge
Time frame: Day 90
90-day hospital readmission
Readmission to the hospital after discharge and within 90 days of randomization
Time frame: Day 90
Plan to share: 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.
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Oct 2026, 36 months after the start.
Of 321 non-industry interventional studies with no phase under Hypoxia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 36 months is above that.
Counting every sponsor, half of 351 studies reached it within 12 months; a quarter within 3 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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