NCT05754034

Brief 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. 1.For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality?
  2. 2.What are the facilitators and barriers to using high flow oxygen in these settings?
  3. 3.Does high flow or standard flow oxygen use more oxygen?

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
3 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

February 7, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 11, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

February 7, 2023

Last Update Submit

January 8, 2026

Conditions

Acute Hypoxemia

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    Death between randomization and end of hospitalization

    Day 90

Secondary Outcomes (8)

  • 90-day mortality

    Day 90

  • 90-day functional status

    Day 90

  • Need for mechanical ventilation

    Day 90

  • Days requiring oxygen

    Day 90

  • Hospital length of stay

    Day 90

  • +3 more secondary outcomes

Other Outcomes (1)

  • Oxygen consumption

    Day 90

Study Arms (2)

High flow oxygen

EXPERIMENTAL

Heated and humidified oxygen delivered via high flow oxygen device through nasal cannula, up to 60 liters per minute of flow.

Device: High flow oxygen

Standard flow oxygen

ACTIVE COMPARATOR

Oxygen delivered via standard oxygen devices at standard flows up to 15 liters per minute: nasal cannula, face mask, or nonrebreather mask.

Other: Standard flow oxygen

Interventions

High flow oxygenDEVICE

humidified and heated oxygen delivered at high flow rates via nasal cannula, with protocol to target SpO2 90-94%

High flow oxygen
Standard flow oxygenOTHER

oxygen delivered at standard flow rates via nasal cannula, facemask, or nonrebreather mask, with protocol to target SpO2 90-94%

Standard flow oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AIC Kijabe Hospital

Kijabe, Kenya

RECRUITING

Nakuru Level V Hospital

Nakuru, Kenya

RECRUITING

Queen Elizabeth Central Hospital

Blantyre, Malawi

RECRUITING

The University Teaching Hospital of Butare (CHUB)

Huye, Rwanda

RECRUITING

The University Teaching Hospital of Kigali (CHUK)

Kigali, Rwanda

RECRUITING

Study Officials

  • Elisabeth Riviello, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Riviello, MD, MPH

CONTACT

+1 617 447 5131eriviell@bidmc.harvard.edu

Theogene Twagirumugabe, MD, PhD

CONTACT

+250 788 539 904twagirumugabe@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

February 7, 2023

First Posted

March 3, 2023

Study Start

October 11, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers for the trial overall. IPD is owned and managed by each of the sites for the trial, in accordance with the data protection requirements of each country where the sites are located. Individual sites may decide to share their own IPD with other researchers.

Locations

MA(1)RW(2)KE(2)