NCT04693403

Brief Summary

The dearth of Intensive care units in low resource settings portends for poor outcomes amongst patients with acute hypoxemic respiratory failure (AHRF) . To our knowledge, the effect of CPAP and HFNC on major outcomes has not been assessed in adults with AHRF in resource-limited settings. The aim of this prospective, multicenter, randomized, controlled, trial is to determine whether High-flow oxygen through a nasal cannula (HFNC) or Continuous positive airway pressure (CPAP) system can reduce mortality among patients with acute hypoxemic respiratory failure (AHRF) in a limited resource setting as compared with standard low flow oxygen therapy?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
705

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

17 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 6, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

December 6, 2020

Last Update Submit

August 11, 2025

Conditions

Acute Respiratory Failure With HypoxiaAcute Respiratory Distress SyndromeAcute Lung Injury

Keywords

Acute Hypoxemic Respiratory FailureAcute Respiratory Distress SyndromeCPAPHFNCLow Income Countries

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Number of study participants deceased at day 28 of study randomisation

    28 day

Secondary Outcomes (4)

  • Number of patients intubated and ventilator-free

    28 days

  • Patient Tolerance to CPAP or HFNC

    7 days

  • Organ failure free days

    7 days

  • Number of patients who meet criteria for intubation at day 7

    7 days

Study Arms (3)

High-flow oxygen nasal cannula (HFNC)

EXPERIMENTAL

In the high-flow-nasal cannula group, oxygen will be delivered through a heated humidifier and applied continuously through large-bore bi-nasal prongs, with a gas flow rate of 40-60 liters per minute and adjusted based on the clinical response.

Procedure: HFNC

Continuous positive airway pressure (CPAP)

EXPERIMENTAL

Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to the standard treatment. CPAP will be started at 7.5 cm of water. The level will be decreased to 5 cm of water or increased to 10 cm of water as needed based on the clinical response and tolerance.

Procedure: CPAP

Standard Low flow Oxygen Arm

ACTIVE COMPARATOR

Patients assigned to the standard treatment group will receive oxygen delivered through a Non-rebreather face mask until endotracheal intubation, death, or fulfillment of oxygen delivery cessation criteria (an oxygen saturation by pulse oximetry (SpO2) above 92% without oxygen and a respiratory rate below 25 cycles/min).

Procedure: Standard Oxygen

Interventions

HFNCPROCEDURE

40-60l/min humidified oxygen by nasal cannula

Also known as: High-flow oxygen by nasal cannula
High-flow oxygen nasal cannula (HFNC)
CPAPPROCEDURE

Oxygen therapy by boussignac Continuous positive airway pressure face mask

Also known as: Continuous positive airway pressure
Continuous positive airway pressure (CPAP)
Standard OxygenPROCEDURE

Oxygen therapy by low flow (upto 15l/min) by Non-rebreather face mask

Also known as: Standard Oxygen Therapy (low flow)
Standard Low flow Oxygen Arm

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • De novo acute respiratory distress, as defined by dyspnea, use of accessory respiratory muscles, and a respiratory rate of 25 breaths per minute or more,
  • Informed consent obtained in accordance with local regulations;

You may not qualify if:

  • Exacerbation of asthma, chronic obstructive pulmonary disease or another known or suspected chronic respiratory disease;
  • Absolute contraindications to CPAP or HFNC
  • Cardiac arrest; severe ventricular arrhythmia; shock defined by the need for vasopressors (dopamine \> 5 microg/kg/min or adrenaline or noradrenaline at any dose)
  • Altered consciousness (Coma Glasgow Score below 12 points);
  • Do not intubate order, do not resuscitate order, or decision to limit full care taken before obtaining informed consent;
  • Refusal to participate, prior enrolment in the trial, participation in another interventional study on respiratory distress;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Entebbe Regional Referral Hospital

Entebbe, Uganda

Location

St Mary's, Lacor

Gulu, Uganda

Location

Hoima Regional referral Hospital

Hoima, Uganda

Location

Jinja Regional Referral Hospital

Jinja, Uganda

Location

Kabale Regional Referral Hospital

Kabale, Uganda

Location

Mulago National Specialised Hospital

Kampala, 00256, Uganda

Location

Kampala hospital

Kampala, Uganda

Location

Kiruddu National referral Hospital

Kampala, Uganda

Location

Naguru Referral Hospital

Kampala, Uganda

Location

Nsambya Hospital

Kampala, Uganda

Location

Rubaga Hospital

Kampala, Uganda

Location

TMR International Hospital

Kampala, Uganda

Location

Kisoro District Hospital

Kisoro, Uganda

Location

Masaka regional Referral Hospital

Masaka, Uganda

Location

Mbale Regional referral Hospital

Mbale, Uganda

Location

Mbarara Regional referral Hospital

Mbarara, Uganda

Location

Mengo Hospital

Mengo, Uganda

Location

Related Publications (1)

  • Kwizera A, Kabatoro D, Owachi D, Kansiime J, Kateregga G, Nanyunja D, Sendagire C, Nyakato D, Olaro C, Audureau E, Mekontso Dessap A. Respiratory support with standard low-flow oxygen therapy, high-flow oxygen therapy or continuous positive airway pressure in adults with acute hypoxaemic respiratory failure in a resource-limited setting: protocol for a randomised, open-label, clinical trial - the Acute Respiratory Intervention StudiEs in Africa (ARISE-AFRICA) study. BMJ Open. 2024 Jul 1;14(6):e082223. doi: 10.1136/bmjopen-2023-082223.

    PMID: 38951007DERIVED

Related Links

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung InjuryRespiratory Insufficiency

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Arthur Kwizera, MD

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stepped wedge cluster randomised trial (8 Clusters).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2020

First Posted

January 5, 2021

Study Start

March 13, 2023

Primary Completion

January 15, 2024

Study Completion

March 31, 2024

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified data, upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Upon study completion, in perpetuity.
Access Criteria
By email.

Locations

UG(17)