Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation

Overview

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

• Device High flow oxygen
  humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%
• Other Standard flow oxygen
  oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%

Primary outcome measures

• In-hospital mortality [Time frame: Day 90]

Secondary outcome measures (8)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Kenya · 2 centers

• AIC Kijabe Hospital — Kijabe
• Nakuru Level V Hospital — Nakuru

Rwanda · 2 centers

• The University Teaching Hospital of Butare (CHUB) — Huye
• The University Teaching Hospital of Kigali (CHUK) — Kigali

Malawi · 1 center

• Queen Elizabeth Central Hospital — Blantyre

Identifiers

NCT: NCT05754034 · 2022P001102 · 222165/Z/20/Z

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗