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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Kenya
AIC Kijabe Hospital
RECRUITING
Kijabe
Nakuru Level V Hospital
RECRUITING
Nakuru
Malawi
Queen Elizabeth Central Hospital
RECRUITING
Blantyre
Rwanda
The University Teaching Hospital of Butare (CHUB)
RECRUITING
Huye
The University Teaching Hospital of Kigali (CHUK)
RECRUITING
Kigali
Contact Information
Primary
Elisabeth Riviello, MD, MPH
eriviell@bidmc.harvard.edu
+1 617 447 5131
Backup
Theogene Twagirumugabe, MD, PhD
twagirumugabe@gmail.com
+250 788 539 904
Time Frame
Start Date: 2023-10-11
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 1054
Treatments
Experimental: High flow oxygen
Heated and humidified oxygen delivered via high flow oxygen device through nasal cannula, up to 60 liters per minute of flow.
Active_comparator: Standard flow oxygen
Oxygen delivered via standard oxygen devices at standard flows up to 15 liters per minute: nasal cannula, face mask, or nonrebreather mask.
Related Therapeutic Areas
Sponsors
Collaborators: Wellcome Trust
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov