Clinical trial NCT05754034: Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
Official title: Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxemia
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2023-03-03
Enrollment: 1054
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: In-hospital mortality
timeFrame: Day 90
Secondary outcomes:
measure: 90-day mortality
timeFrame: Day 90
measure: 90-day functional status
timeFrame: Day 90
measure: Need for mechanical ventilation
timeFrame: Day 90
measure: Days requiring oxygen
timeFrame: Day 90
measure: Hospital length of stay
timeFrame: Day 90
measure: ICU length of stay
timeFrame: Day 90
measure: Time to meeting criteria for need for escalation to either NIV or invasive ventilation
timeFrame: Day 90
measure: Time to escalation to either NIV or invasive ventilation
timeFrame: Day 90
Other outcomes:
measure: Oxygen consumption
timeFrame: Day 90
Locations:
city: Kijabe
country: Kenya
facility: AIC Kijabe Hospital
city: Nakuru
country: Kenya
facility: Nakuru Level V Hospital
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
city: Huye
country: Rwanda
facility: The University Teaching Hospital of Butare (CHUB)
city: Kigali
country: Rwanda
facility: The University Teaching Hospital of Kigali (CHUK)
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Elisabeth Riviello, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: