Protocol No: ECCT/23/06/01 Date of Protocol: 17-04-2023

Study Title:

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

Study Objectives:

Primary Objectives

To determine whether:

  1. High flow oxygen (HFO) will decrease in-hospital mortality compared with standard flow oxygen (SFO);
  2. Protocolized HFO and SFO will decrease in-hospital mortality compared with baseline oxygen therapy.

Secondary Objectives

To assess:

  1. Long-term mortality outcomes
  2. Long-term functional status outcomes
  3. Hospital care outcomes including need for mechanical ventilation, days requiring oxygen, hospital length of stay, and ICU length of stay
  4. Time to intubation
  5. Time to meeting clinical criteria for intubation
  6. Oxygen consumption
  7. Cost effectiveness and affordability
  8. Feasibility including quantitative and qualitative assessments of inputs needed

Feasibility outcomes

1. Oxygen consumption
2. Cost effectiveness
3. Affordability
4. Acceptability
5. Input resources and processes
Laymans Summary:

When people in low-income countries have serious breathing problems, it can be a big issue. The COVID-19 pandemic has made this problem worse. In these countries, there is a shortage of oxygen and machines that help people breathe. In richer countries, a treatment called high flow oxygen therapy (HFO) has been successful in reducing deaths and the need for inserting a tube in the throat to help with breathing. But we don't know if it works the same way in low-income countries. Current guidelines suggest using HFO for COVID-19 patients, but the results of studies on HFO have been mixed. This study wants to see how two different treatments, standard flow oxygen (SFO) and HFO, affect the chances of dying and how easy they are to use in low-income countries. We need to establish a standard way of giving SFO to compare it properly with HFO.

Abstract of Study:

Acute hypoxemic respiratory failure is a significant Public Health crisis in low-income countries (LICs). The COVID-19 pandemic has exacerbated the burden of respiratory failure in LICs. Oxygen and mechanical ventilators, essential for critical care, are extremely limited in LICs. High flow oxygen therapy (HFO) has shown promising results in reducing mortality and the need for intubation in high-income countries. However, its effectiveness and implementation in LICs are unknown. Current guidelines recommend HFO over other oxygen delivery methods for COVID-19 patients. While some studies have been conducted on HFO in COVID-19 patients, results are mixed. This study aims to assess the impact of protocolized standard flow oxygen (SFO) and HFO on mortality and implementation factors in LICs. Establishing a standard of care for SFO is crucial to evaluate the specific impact of HFO. The study aims to improve understanding of the interventions' effects, cost-effectiveness, and real-world application in diverse settings. The study will be conducted in five academic referral hospitals in Rwanda, Malawi, and Kenya. The study will be a randomized control study without blinding for participants, participants' surrogates, study staff, and clinical staff.