Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05754034

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

Led by Beth Israel Deaconess Medical Center · Updated on 2026-01-12

1600

Participants Needed

5

Research Sites

168 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

W

Wellcome Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Admitted to a study site hospital within 24 hours prior to screening
  • Blood oxygen saturation (SpO2) below 90% at first assessment or currently receiving oxygen
Not Eligible

You will not qualify if you...

  • High likelihood of death within 24 hours of admission
  • Patient or caregiver refuses to participate
  • History of chronic respiratory failure with SpO2 below 90% or oxygen dependence for at least three months
  • Anatomical issues preventing nasal cannula use
  • Intubation or non-invasive ventilation before screening
  • Known hypoxemia at transferring facility for more than 48 hours
  • Lack of availability of either standard flow or high flow oxygen devices or supplies at randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

AIC Kijabe Hospital

Kijabe, Kenya

Actively Recruiting

2

Nakuru Level V Hospital

Nakuru, Kenya

Actively Recruiting

3

Queen Elizabeth Central Hospital

Blantyre, Malawi

Actively Recruiting

4

The University Teaching Hospital of Butare (CHUB)

Huye, Rwanda

Actively Recruiting

5

The University Teaching Hospital of Kigali (CHUK)

Kigali, Rwanda

Actively Recruiting

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Research Team

E

Elisabeth Riviello, MD, MPH

CONTACT

T

Theogene Twagirumugabe, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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