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

NCT05754034 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Acute Hypoxemia

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%

Sponsors & Collaborators

Principal Investigators

  • Elisabeth Riviello, MD, MPH · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-11
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Kenya
  • Malawi
  • Rwanda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754034 on ClinicalTrials.gov