Acute Respiratory Failure With HypoxiaARISE-AFRICANCT04693403
The Acute Respiratory Intervention StudiEs in Africa (ARISE-AFRICA) Study
A study testing HFNC, CPAP and Standard Oxygen in people with Acute Respiratory Failure With Hypoxia and Acute Respiratory Distress Syndrome, run by Makerere University at 17 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acute Respiratory Failure With Hypoxia, Acute Respiratory Distress Syndrome, Acute Lung Injury
- What is being tested?
- HFNC, CPAP and Standard Oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- 17 sitesUganda
- Study dates
- 13 Mar 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- Hypoxemia, as defined by a ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg or a oxygen saturation by pulse oximetry SpO2/FiO2 ratio <315 will be considered for inclusion
- Informed consent obtained in accordance with local regulations;
Who cannot join
- 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;
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Uganda17 sites
Entebbe Regional Referral Hospital
Entebbe
St Mary's, Lacor
Gulu
Hoima Regional referral Hospital
Hoima
Jinja Regional Referral Hospital
Jinja
Kabale Regional Referral Hospital
Kabale
Mulago National Specialised Hospital
Kampala, 00256
Kampala hospital
Kampala
Kiruddu National referral Hospital
Kampala
Naguru Referral Hospital
Kampala
Nsambya Hospital
Kampala
Rubaga Hospital
Kampala
TMR International Hospital
Kampala
Kisoro District Hospital
Kisoro
Masaka regional Referral Hospital
Masaka
Mbale Regional referral Hospital
Mbale
Mbarara Regional referral Hospital
Mbarara
Mengo Hospital
Mengo
About this study
Official title: A Multicentre, Randomized, Clinical Trial of Respiratory Support With Standard Low Flow Oxygen Therapy, Continuous Positive Airway Pressure, and High-flow Oxygen Therapy in Adults With Acute Hypoxemic Respiratory Failure in Uganda
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?
Read the detailed description
The care for the critically ill patient typically takes place in the intensive care unit (ICU). ICU care is quite expensive, even in resource rich countries. The most common reason for ICU admission globally is respiratory support for acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality, especially in low income countries (LICs), given the scarce availability of invasive mechanical ventilation. Some studies suggest that administration of ventilatory support through a mask may be effective in resource-limited settings. However, there is no clinical study data in adults to support this evidence. Human and material constraints are major barriers for the care of critically-ill patients in resource limited settings , advocating the need for a frugal approach. Furthermore, the scarcity of intensive care unit care in LICs contributes to a high mortality among acutely ill patients. The current corona virus pandemic has further highlighted the need for frugal acute care interventions in LICs.
Continuous positive airway pressure (CPAP) is a simple to use and affordable technique for noninvasive ventilatory support. High-flow oxygen through a nasal cannula (HFNC) may also offer an alternative in patients with hypoxemia. The high flow rates may also decrease physiological dead space by flushing expired carbon dioxide from the upper airway, a process that potentially explains the observed decrease in the work of breathing.
Frugal CPAP or HFNC , as compared with standard oxygen therapy, could reduce the mortality among adults presenting with AHRF in a resource-limited setting.
- Conditions
- Acute Respiratory Failure With Hypoxia, Acute Respiratory Distress Syndrome, Acute Lung Injury
- Being tested
- HFNC, CPAP, Standard Oxygen
- Keywords
- Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome, CPAP, HFNC, Low Income Countries
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCProcedure or surgery
Also called High-flow oxygen by nasal cannula
40-60l/min humidified oxygen by nasal cannula
CPAPProcedure or surgery
Also called Continuous positive airway pressure
Oxygen therapy by boussignac Continuous positive airway pressure face mask
Standard OxygenProcedure or surgery
Also called Standard Oxygen Therapy (low flow)
Oxygen therapy by low flow (upto 15l/min) by Non-rebreather face mask
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Procedure: Standard Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of study participants deceased at day 28 of study randomisation
Measured: 28 day
Secondary outcomes (4)
Number of patients intubated and ventilator-free
Number of patients intubated and ventilator-free at 28 days from randomisation
Measured: 28 days
Patient Tolerance to CPAP or HFNC
Patients will be assessed using the Likert scale
Measured: 7 days
Organ failure free days
Number of days from randomisation free of organ failure
Measured: 7 days
Number of patients who meet criteria for intubation at day 7
Number of patients who meet criteria for intubation at day 7 of randomisation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start13 Mar 2023
- Primary completion15 Jan 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge cluster randomised trial (8 Clusters).
- Masking
- None (open label)
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- THRiVE, Paris 12 Val de Marne University, Wellcome Trust
- Responsible party
- Principal investigator, College of Health Sciences, Makerere University
- Investigators
- Arthur Kwizera, MD, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693403
- Sponsor's protocol ID
- ARISE_001
- Acronym
- ARISE-AFRICA
- Status last verified
- Aug 2025
- First submitted
- 6 Dec 2020
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data, upon reasonable request.
Publications
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.
PubMed 38951007
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Clinical Trial of Respiratory Support With Standard Low Flow Oxygen Therapy, Continuous Positive Airway Pressure, and High-flow Oxygen Therapy in Adults With Acute Hypoxemic Respiratory Failure in Uganda
- ClinicalTrials.gov ID
- NCT04693403
- Acronym / sponsor ID
- ARISE-AFRICA / ARISE_001
- Conditions
- Acute Respiratory Failure With Hypoxia, Acute Respiratory Distress Syndrome, Acute Lung Injury
- Keywords
- Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome, CPAP, HFNC, Low Income Countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- THRiVE, Paris 12 Val de Marne University, Wellcome Trust
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The care for the critically ill patient typically takes place in the intensive care unit (ICU). ICU care is quite expensive, even in resource rich countries. The most common reason for ICU admission globally is respiratory support for acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality, especially in low income countries (LICs), given the scarce availability of invasive mechanical ventilation. Some studies suggest that administration of ventilatory support through a mask may be effective in resource-limited settings. However, there is no clinical study data in adults to support this evidence. Human and material constraints are major barriers for the care of critically-ill patients in resource limited settings , advocating the need for a frugal approach. Furthermore, the scarcity of intensive care unit care in LICs contributes to a high mortality among acutely ill patients. The current corona virus pandemic has further highlighted the need for frugal acute care interventions in LICs.
Continuous positive airway pressure (CPAP) is a simple to use and affordable technique for noninvasive ventilatory support. High-flow oxygen through a nasal cannula (HFNC) may also offer an alternative in patients with hypoxemia. The high flow rates may also decrease physiological dead space by flushing expired carbon dioxide from the upper airway, a process that potentially explains the observed decrease in the work of breathing.
Frugal CPAP or HFNC , as compared with standard oxygen therapy, could reduce the mortality among adults presenting with AHRF in a resource-limited setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Stepped wedge cluster randomised trial (8 Clusters).
| Arm | Type | Receives |
|---|---|---|
| High-flow oxygen nasal cannula (HFNC) | Experimental | Procedure: HFNCIn 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. |
| Continuous positive airway pressure (CPAP) | Experimental | Procedure: CPAPPatients 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. |
| Standard Low flow Oxygen Arm | Active comparator | Procedure: Standard OxygenPatients 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). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
- Hypoxemia, as defined by a ratio of the partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg or a oxygen saturation by pulse oximetry SpO2/FiO2 ratio <315 will be considered for inclusion
- Informed consent obtained in accordance with local regulations;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNCAlso: High-flow oxygen by nasal cannula40-60l/min humidified oxygen by nasal cannula | Procedure or surgery | High-flow oxygen nasal cannula (HFNC) |
| CPAPAlso: Continuous positive airway pressureOxygen therapy by boussignac Continuous positive airway pressure face mask | Procedure or surgery | Continuous positive airway pressure (CPAP) |
| Standard OxygenAlso: Standard Oxygen Therapy (low flow)Oxygen therapy by low flow (upto 15l/min) by Non-rebreather face mask | Procedure or surgery | Standard Low flow Oxygen Arm |
Primary outcome
Mortality
Time frame: 28 day
Number of study participants deceased at day 28 of study randomisation
4 secondary outcomes
Number of patients intubated and ventilator-free
Time frame: 28 days
Patient Tolerance to CPAP or HFNC
Time frame: 7 days
Organ failure free days
Time frame: 7 days
Number of patients who meet criteria for intubation at day 7
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Derived from this study: PubMed 38951007Kwizera 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data, upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Kwizera, MD principal investigator
Makerere University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC, CPAP and Standard Oxygen in people with Acute Respiratory Failure With Hypoxia and Acute Respiratory Distress Syndrome, run by Makerere University at 17 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.