Acute Hypoxemic Respiratory FailureBAGCPAP-RNCT07460427
Bag CPAP vs Standard Oxygen Therapy in Acute Hypoxemic Respiratory Failure
A study testing Bag CPAP and Standard oxygen in people with Acute Hypoxemic Respiratory Failure, run by Prof RWABIHAMA Jean Paul at 1 site in Rwanda.
Trial summary
Acute Hypoxemic Respiratory Failure (AHRF) is one of the prevalent causes of admission around the world and is associated with high mortality in resource-limited settings. Limited access to invasive mechanical ventilation is among the contributing factors to poor outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Bag CPAP and Standard oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteRwanda
- Study dates
- 20 Apr 2026to 20 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion criteria All patients aged 18 years or older will be included in the study if they meet the following criteria:
- De novo acute respiratory distress, characterized by the presence of dyspnea at rest, the use of accessory muscles for breathing, or a respiratory rate of 25 cycles per minute or more.
- Hypoxemia, defined as a SpO2/FiO2 ratio less than 315 or a PaO2/FiO2 ratio less than 300 mmHg (if arterial blood gas is available) despite an oxygen therapy of 6 L/min. FiO2 will be estimated by the rule of 3% (Coudroy formula)(18,22). SpO2 should be less than 98% when assessing the SpO2/FiO2 ratio.
- Exclusion criteria
Patients with one of the following criteria will be excluded from the study:
- Absolute contraindications to CPAP: patient's refusal, uncontrollable vomiting, upper gastrointestinal bleeding, open or sucking chest wound, pneumothorax not drained, craniofacial trauma, severe burns to the face, severe upper airway obstruction, traumatic tetraplegia at the initial stage, tracheostomy.
- Moderate to massive pleural effusion not drained
- Cardiac arrest, severe ventricular arrhythmias, and shock defined as the need for vasopressor support (adrenaline, noradrenaline, or dopamine)
- Altered level of consciousness (GCS below 12), repetitive convulsions, or status epilepticus
- Do not intubate or resuscitate order before the inclusion in the study
- Refusal to participate, already included in the study, enrollment in another interventional trial on acute respiratory failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rwanda1 site
University of Rwanda
Kigali
Bruce Nzobele MUTEMBE, MD, +250 783 874 050, brucemutembe@gmail.com
Jean Paul RWABIHAMA, MD, PhD, +250 780 859 127, jeanpaulrwabihama@gmail.com
About this study
Official title: Bag CPAP Versus Standard Oxygen Care for the Management of Acute Hypoxemic Respiratory Failure in Adults: A Randomized Controlled Trial
Acute Hypoxemic Respiratory Failure (AHRF) is one of the prevalent causes of admission around the world and is associated with high mortality in resource-limited settings. Limited access to invasive mechanical ventilation is among the contributing factors to poor outcomes. The Bag CPAP may be useful in reducing the need for intubation and therefore mortality in patients with AHRF but data are lacking. This study aims to determine whether the Bag CPAP compared to standard oxygen care, could reduce the percentage of patients with criteria for intubation in patients with AHRF.
This is a prospective randomized, open-label, controlled trial in which patients presenting at the emergency room in Rwanda will be randomly assigned to receive standard oxygen therapy or Bag CPAP. The primary endpoint is the percentage of patients with criteria for intubation at day 7. Secondary endpoints include the tolerance of the Bag CPAP, overall 28-day mortality rate, mortality rate of intubated patients on mechanical ventilation at day 28, percentage of patients intubated at 28 days, ventilator-free days at day 28, interval between the initiation of treatment and the onset of intubation criteria, the interval between the time when criteria for intubation are met and intubation, organ failure-free days at day 7 and length of hospital stay.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Bag CPAP, Standard oxygen
- Keywords
- CPAP, Randomized controlled trial, Respiratory Failure, Low resource setting
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bag CPAPDevice
Bag CPAP sessions in addition to standard oxygen therapy. The Bag CPAP will be delivered continuously for the first 6 to 12 hours, then for sessions of at least 4 hours per day.
Standard oxygenDevice
Standard oxygen therapy via nasal prongs, simple facial masks, or non-rebreather masks, depending on the need, until endotracheal intubation, death, or the presence of oxygen therapy cessation criteria
| Study group | Role | What they receive |
|---|---|---|
| Oxygen+Bag CPAP | Experimental | Patients will receive oxygen and Bag CPAP sessions Receives: Device: Bag CPAP; Device: Standard oxygen |
| Oxygen | Active comparator | Patients will receive oxygen Receives: Device: Standard oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with criteria for intubation at day 7
Predetermined criteria for endotracheal intubation and mechanical ventilation will be considered.
Measured: Day-7
Secondary outcomes (7)
Tolerance of the Bag CPAP
Percentage of patients with facial skin abrasion and necrosis, aspiration, or sinusitis up to day 28.
Measured: up to day-28
Mortality rate of intubated patients on mechanical ventilation
Invasive mechanical ventilation is defined as the delivery of positive pressure via an endotracheal or tracheostomy tube.
Measured: Up to day-28
Ventilator-free days
Measured: up to day-28
Organ failure-free days
Measured: Day-7
Mortality rate
Measured: Up to day-28
Duration of hospital stay
Measured: Up to day-28
Percentage of patients intubated
Measured: Day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic Respiratory FailureStudies 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
- Group oxygen vs Group oxygen+Bag CPAP
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof RWABIHAMA Jean Paul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof RWABIHAMA Jean Paul, University of Rwanda
- Investigators
- Armand Dessap MEKONSTO, MD, PhD, Study director, University of Paris-Est CretelJean Paul RWABIHAMA, MD,PhD, Study director, University of RwandaSabin Nsanzimana, MD, PhD, Study chair, Ministry of Health, Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460427
- Sponsor's protocol ID
- URICU250
- Acronym
- BAGCPAP-R
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Beaufort E, Carteaux G, Morin F, Lesimple A, Haudebourg AF, Fresnel E, Duval D, Broc A, Mercat A, Brochard L, Savary D, Beloncle F, Mekontso Dessap A, Richard JC. A new reservoir-based CPAP with low oxygen consumption: the Bag-CPAP. Crit Care. 2023 Jul 4;27(1):262. doi: 10.1186/s13054-023-04542-2.
PubMed 37403149Kwizera A, Nakibuuka J, Nakiyingi L, Sendagire C, Tumukunde J, Katabira C, Ssenyonga R, Kiwanuka N, Kateete DP, Joloba M, Kabatoro D, Atwine D, Summers C. Acute hypoxaemic respiratory failure in a low-income country: a prospective observational study of hospital prevalence and mortality. BMJ Open Respir Res. 2020 Nov;7(1):e000719. doi: 10.1136/bmjresp-2020-000719.
PubMed 33148779Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bag CPAP Versus Standard Oxygen Care for the Management of Acute Hypoxemic Respiratory Failure in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07460427
- Acronym / sponsor ID
- BAGCPAP-R / URICU250
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- CPAP, Randomized controlled trial, Respiratory Failure, Low resource setting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Prof RWABIHAMA Jean PaulUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
Acute Hypoxemic Respiratory Failure (AHRF) is one of the prevalent causes of admission around the world and is associated with high mortality in resource-limited settings. Limited access to invasive mechanical ventilation is among the contributing factors to poor outcomes. The Bag CPAP may be useful in reducing the need for intubation and therefore mortality in patients with AHRF but data are lacking. This study aims to determine whether the Bag CPAP compared to standard oxygen care, could reduce the percentage of patients with criteria for intubation in patients with AHRF.
This is a prospective randomized, open-label, controlled trial in which patients presenting at the emergency room in Rwanda will be randomly assigned to receive standard oxygen therapy or Bag CPAP. The primary endpoint is the percentage of patients with criteria for intubation at day 7. Secondary endpoints include the tolerance of the Bag CPAP, overall 28-day mortality rate, mortality rate of intubated patients on mechanical ventilation at day 28, percentage of patients intubated at 28 days, ventilator-free days at day 28, interval between the initiation of treatment and the onset of intubation criteria, the interval between the time when criteria for intubation are met and intubation, organ failure-free days at day 7 and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group oxygen vs Group oxygen+Bag CPAP
| Arm | Type | Receives |
|---|---|---|
| Oxygen+Bag CPAP | Experimental | Device: Bag CPAP, Device: Standard oxygenPatients will receive oxygen and Bag CPAP sessions |
| Oxygen | Active comparator | Device: Standard oxygenPatients will receive oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Bag CPAPBag CPAP sessions in addition to standard oxygen therapy. The Bag CPAP will be delivered continuously for the first 6 to 12 hours, then for sessions of at least 4 hours per day. | Device | Oxygen+Bag CPAP |
| Standard oxygenStandard oxygen therapy via nasal prongs, simple facial masks, or non-rebreather masks, depending on the need, until endotracheal intubation, death, or the presence of oxygen therapy cessation criteria | Device | Oxygen, Oxygen+Bag CPAP |
Primary outcome
Percentage of patients with criteria for intubation at day 7
Time frame: Day-7
Predetermined criteria for endotracheal intubation and mechanical ventilation will be considered.
7 secondary outcomes
Tolerance of the Bag CPAP
Time frame: up to day-28
Mortality rate of intubated patients on mechanical ventilation
Time frame: Up to day-28
Ventilator-free days
Time frame: up to day-28
Organ failure-free days
Time frame: Day-7
Mortality rate
Time frame: Up to day-28
Duration of hospital stay
Time frame: Up to day-28
Percentage of patients intubated
Time frame: Day-28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 37403149de Beaufort E, Carteaux G, Morin F, Lesimple A, Haudebourg AF, Fresnel E, Duval D, Broc A, Mercat A, Brochard L, Savary D, Beloncle F, Mekontso Dessap A, Richard JC. A new reservoir-based CPAP with low oxygen consumption: the Bag-CPAP. Crit Care. 2023 Jul 4;27(1):262. doi: 10.1186/s13054-023-04542-2.
- Background: PubMed 33148779Kwizera A, Nakibuuka J, Nakiyingi L, Sendagire C, Tumukunde J, Katabira C, Ssenyonga R, Kiwanuka N, Kateete DP, Joloba M, Kabatoro D, Atwine D, Summers C. Acute hypoxaemic respiratory failure in a low-income country: a prospective observational study of hospital prevalence and mortality. BMJ Open Respir Res. 2020 Nov;7(1):e000719. doi: 10.1136/bmjresp-2020-000719.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Individual participant dataSharing planned: No
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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.
Armand Dessap MEKONSTO, MD, PhD study director
University of Paris-Est Cretel
Jean Paul RWABIHAMA, MD,PhD study director
University of Rwanda
Sabin Nsanzimana, MD, PhD study chair
Ministry of Health, Rwanda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bag CPAP and Standard oxygen in people with Acute Hypoxemic Respiratory Failure, run by Prof RWABIHAMA Jean Paul at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce Nzobele MUTEMBE, MD (+250783874050 ext. +250780859127, brucemutembe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with criteria for intubation at day 7 (time frame: Day-7). 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 NCT07460427, which also lists 3 linked publications.
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 19 Mar 2026.