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| ID | Type | Description | Link |
|---|---|---|---|
| 222165/Z/20/Z | Other Grant/Funding Number | Wellcome Trust (WT) |
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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow oxygen | Device | humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94% |
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| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Death between randomization and end of hospitalization | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day mortality | Death between randomization and 90 days | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen consumption | Total oxygen consumed during hospitalization | Day 90 |
| 90-day hospital re-admission | Re-admission to the hospital after discharge and before 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Riviello, MD, MPH | Contact | +1 617 447 5131 | eriviell@bidmc.harvard.edu | |
| Theogene Twagirumugabe, MD, PhD | Contact | +250 788 539 904 | twagirumugabe@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Riviello, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIC Kijabe Hospital | Recruiting | Kijabe | Kenya |
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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| Standard flow oxygen | Other | oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94% |
|
| 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 | Day 90 |
| Days requiring oxygen | Days requiring oxygen from randomization to end of hospitalization | Day 90 |
| Hospital length of stay | Days from randomization to hospital discharge or death | Day 90 |
| ICU length of stay | Total days in the ICU during hospitalization | 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 | Day 90 |
| Time to escalation to either NIV or invasive ventilation | Time to escalation to non-invasive ventilation or invasive ventilation | Day 90 |
| 90 days |
| Nakuru Level V Hospital | Recruiting | Nakuru | Kenya |
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| Queen Elizabeth Central Hospital | Recruiting | Blantyre | Malawi |
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| The University Teaching Hospital of Butare (CHUB) | Recruiting | Huye | Rwanda |
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| The University Teaching Hospital of Kigali (CHUK) | Recruiting | Kigali | Rwanda |
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