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Search / Trial NCT05754034

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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Feb 21, 2023

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether high flow oxygen can help adult patients with low oxygen levels (a condition called acute hypoxemia) more effectively than standard flow oxygen in hospitals in East Africa. The researchers want to find out if using high flow oxygen reduces the risk of death, how much oxygen each method uses, and what challenges or advantages there are in using high flow oxygen in these settings.

To participate in the study, individuals must be at least 18 years old, have been admitted to the hospital within the last 24 hours, and have low oxygen levels (less than 90%) or be receiving oxygen already. Participants will be randomly assigned to receive either high flow oxygen or standard flow oxygen through different types of masks or tubes. The study aims to gather important information that could improve how patients are treated in places where medical resources may be limited. If you or someone you know is eligible and interested in participating, this trial could help shape future treatments for similar conditions.

Gender

ALL

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.

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center (BIDMC) is a leading academic medical center located in Boston, Massachusetts, affiliated with Harvard Medical School. Renowned for its commitment to cutting-edge research and innovation in healthcare, BIDMC fosters a collaborative environment that integrates patient care, education, and scientific investigation. The center actively sponsors clinical trials across a variety of disciplines, aiming to advance medical knowledge and improve patient outcomes. With a focus on translational medicine, BIDMC's research initiatives engage multidisciplinary teams to address complex health challenges and translate findings into effective therapeutic strategies.

Locations

Blantyre, , Malawi

Kijabe, , Kenya

Kigali, , Rwanda

Nakuru, , Kenya

Huye, , Rwanda

Patients applied

0 patients applied

Trial Officials

Elisabeth Riviello, MD, MPH

Principal Investigator

Beth Israel Deaconess Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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