Acute Hypoxemia
Conditions
Brief 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. 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.
Interventions
OTHERStandard flow oxygen
oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%
DEVICEHigh flow oxygen
humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%
Sponsors
Wellcome Trust
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | Day 90 | Death between randomization and end of hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | Day 90 | Death between randomization and 90 days |
| 90-day functional status | Day 90 | Functional status 90 days after randomization, as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) |
| Need for mechanical ventilation | Day 90 | Met objective criteria for need to escalate respiratory therapy to NIV or invasive ventilation, or escalated to NIV or mechanical ventilation |
| Days requiring oxygen | Day 90 | Days requiring oxygen from randomization to end of hospitalization |
| ICU length of stay | Day 90 | Total days in the ICU during hospitalization |
| Time to meeting criteria for need for escalation to either NIV or invasive ventilation | Day 90 | Time to meeting objective clinical criteria for escalation to non-invasive ventilation or invasive ventilation |
| Time to escalation to either NIV or invasive ventilation | Day 90 | Time to escalation to non-invasive ventilation or invasive ventilation |
| Hospital length of stay | Day 90 | Days from randomization to hospital discharge or death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oxygen consumption | Day 90 | Total oxygen consumed during hospitalization |
Countries
Kenya, Malawi, Rwanda
Contacts
Primary ContactElisabeth Riviello, MD, MPH
Backup ContactTheogene Twagirumugabe, MD, PhD
Outcome results
None listed