Acute Respiratory FailureNCT06912360
Continous Positive Airway Pressure (CPAP) Support for Acute Hypoxemic Respiratory Failure in Burkina Faso
A study testing CPAP in people with Acute Respiratory Failure, run by Université NAZI BONI at 4 sites in Burkina Faso.
Trial summary
Acute respiratory failure (ARF) is a frequent medical emergency, involving high costs for health organizations and patients who often require intensive care and respiratory assistance. According to an international study, 61% of hypoxemic patients in intensive care receive invasive ventilation [3]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- CPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesBurkina Faso
- Study dates
- 9 Jul 2025to 20 Feb 2026
- 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
Who may be able to join
- All patients aged 18 years and older will be included in the study if they meet at least one of the following criteria :
- Acute respiratory distress, defined as dyspnea respiratory rate ≥ 25 cycles/min
- Hypoxemia, defined as the need for more 6 liters of oxygen to maintain an oxygen saturation (SpO2) of ≥ 92%. The fraction of inspired oxygen (FiO2) will be estimated using the 3% rule.
Who cannot join
- Patients with any of the following criteria will not be included in the study:
- Pregnant or breastfeeding women
- Persons deprived of their liberty
- Exacerbation of asthma, chronic obstructive pulmonary disease, or another chronic respiratory disease
- Moderate to large amount of unilateral or bilateral undrained pleural effusion
- Contraindication to CPAP: patient refusal, undrained pneumothorax, chest injury, repeated or large vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, or tetraplegia in the initial phase
Show all 10Show fewer
- Cardiac arrest, severe arrhythmias, shock requiring the use of vasopressors (norepinephrine, adrenaline, dopamine)
- Altered level of consciousness (Glasgow Coma Scale score < 13), repeated seizures, or status epilepticus
- Medical decision to limit treatment: no intubation, no admission to intensive care
- Refusal to participate in the study or participation in another interventional study on respiratory distress or acute respiratory failure.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Burkina Faso4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire Souro Sanou
Bobo-Dioulasso, Houet, 01 BP 676
Adama Decard Sawadogo, doctor, +22667337419, sadeca@gmail.com
Ismael Guibla, doctor, +22676135113, ismaelguibla@gmail.com
- Not yet recruiting
CHU Yalgado Ouedraogo
Ouagadougou, Kadiogo, 03 BP 702250311655
Martin Lankoande, doctor, +22670606447, m.lansongui@gmail.com
Papougnezambo Bonkoungou, doctor, +22670415444, zambonkoungou@yahoo.fr
- Not yet recruiting
CHU Tengandogo
Ouagadougou, Kadiogo, 03 BP 7067
Imbe Ignace Yaro, doctor, +22670675148, yaroignace@gmail.com
Flavien Kabore, professor, +22670142327, kflavien72@yahoo.fr
- Not yet recruiting
CHU Bogodogo
Ouagadougou, Kadiogo, 14 BP 371
Seif Idriss Salah Traore, doctor, +22670689698, seif_tis@yahoo.fr
Chamir Congo, doctor, +22673380662, congowendpanga20@gmail.com
About this study
Official title: Use of (Continous Positive Airway Pressure) CPAP in the Management of Acute Hypoxemic Respiratory Failure
Acute respiratory failure (ARF) is a frequent medical emergency, involving high costs for health organizations and patients who often require intensive care and respiratory assistance. According to an international study, 61% of hypoxemic patients in intensive care receive invasive ventilation [3]. Invasive mechanical ventilation is often unavailable in low-income countries and non-invasive ventilatory supports such as continuous positive airway pressure (CPAP) and high-flow oxygen therapy (HFO) were very useful during the COVID-19 pandemic. They reduced the rate of intubation and ICU admissions. In addition, CPAP can be used without a ventilator, no electricity is required. So, it could be a support of choice in low-income countries.
Used of Boussignac-type CPAP could potentially reduce the recourse to intubation in patients with acute hypoxemic respiratory failure in a context where access to invasive ventilation remains very limited.
Read the detailed description
- Hypothesis : The use of Boussignac-type CPAP could reduce the need for intubation in patients with acute respiratory failure in a setting where access to invasive ventilation remains very limited.
- Objectives 2.1 Primary Objective The primary objective is to evaluate the effect of CPAP use on the occurrence of intubation criteria at 7 days in patients presenting with ARF in the emergency department. 2.2 Secondary Objectives The secondary objectives are:
- To assess the impact of CPAP use on 28-day mortality in patients with ARF
- To assess the effectiveness of CPAP use on oxygenation in patients with ARF using the SpO2/FiO2 ratio
- To assess the impact of CPAP use on hospital stay
- To assess the safety of CPAP in patients with ARF 2.3 Ancillary Studies The ancillary studies are:
- To assess the contribution of ultrasound in the management of ARF
- To determine the etiologies and prognosis of ARF
- To determine the etiologies and prognosis of patients with ARDS in intensive care
- To assess the cost of ARF management
- Methodology 3.1 Study Setting
The Study will take place in the four adult university hospitals in Burkina Faso. Patient recruitment will take place during the same period in the emergency and intensive care departments. Patient inclusion in each hospital will be under the responsibility of an emergency department physician or an anesthesiologist-intensive care physician.
3.2 Study Type
This will be an open-label, multicenter, national randomized clinical trial. The type of oxygenation device does not allow for a blinded study.
3.3 Study Designs
Within 3 hours of validating the inclusion criteria, patients will be assigned to one of the two groups after signing the consent form.
- In both groups, the oxygen flow will be adjusted to achieve an SpO2 of 92% or higher. SpO2 will be measured either using a monitor with integrated SpO2 measurement or using a portable device such as the Lifebox. The remainder of the patient's care will be administered according to the etiology of the ARF at the physician's discretion and according to recommandations. Any omission from the administration of study treatment will be noted on the collection sheet.
- In the standard group Patients assigned to the standard treatment group will receive oxygen delivered via nasal prongs, simple face masks, or a high-concentration face mask (as needed) until intubation criteria are met, death occurs, or oxygen discontinuation criteria are met (an SpO2 greater than 92% without oxygen and a respiratory rate less than 25 breaths/min).
Patients who meet the intubation criteria will either be intubated if a bed and a ventilator are available in intensive care, or may receive, at the discretion of the physician, CPAP treatment as backup treatment in crossover, if invasive ventilation is not possible.
- In the CPAP group Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to standard oxygen therapy. All study centers will use a Boussignac device connected to an oronasal mask consisting of a transparent mask and a soft inflatable cushion. The CPAP pressure level will be determined by the oxygen flow rate according to the correlation table. CPAP will start at 7.5 cmH2O (i.e., a Boussignac supply of 25 L/min). The pressure level will be decreased to 5 cmH2O (i.e., a Boussignac supply of 20 L/min) or increased to 10 cmH2O (i.e., a Boussignac supply of 30 L/min) depending on clinical response and tolerance. For at least the first 6 to 12 hours, CPAP will be administered continuously, then intermittently (for at least 6 hours/day) depending on patient tolerance. CPAP will be continued until endotracheal intubation criteria are met, death occurs, or treatment is discontinued according to the following criteria: SpO2 greater than 92% and respiratory rate less than 25 breaths/min with 3 L of oxygen or less between CPAP sessions. The criteria for discontinuing oxygen administration will be the same as in the standard group.
Patients who meet the intubation criteria will either be intubated if a bed and ventilator are available in intensive care, or will continue CPAP treatment if invasive ventilation is not possible.
3.4 Stratification
Randomization will be stratified by study center and baseline hypoxemia status. Stratification block randomization will be performed using a centralized, secure electronic system.
- Conditions
- Acute Respiratory Failure
- Being tested
- CPAP
- Keywords
- CPAP, Acute hypoxemic respiratory failure, Africa
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPOther
Continuous Positive Airway Pressure (CPAP) with Boussignac valve
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Experimental | Continuous CPAP (with Boussignac valve) for the first 6-12 hours, then alternating with standard oxygen therapy. CPAP pressure= 7.5 cmH2O (25L/min) then variations of +/- 2.5 cmH20 according to clinical response and tolerance until weaning from oxygen or presence of intubation criteria Receives: Other: CPAP |
| Standard group | No intervention | Oxygen therapy as required using, simple face masks or high concentration face masks until there are criteria for intubation, or withdrawal from oxygen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with intubation criteria within 7 days
The proportion of patients requiring endotracheal intubation within 7 days after randomization. Intubation will be defined as the insertion of an endotracheal tube for invasive invasive mechanical ventilation
Measured: 7 days after randomization
Secondary outcomes (3)
All cause mortality at 28 days
Proportion of patients who have died from any cause within 28 days after randomization. Mortality will be assessed using medical records and/or direct patient follow-up
Measured: 28 days after randomization
Organ failure-free days at 7 days
Organ failure will be defined using SOFA score or Modified SOFA score. The score ranges from 0 to 24.
Measured: 7 days after randomization
CPAP tolerance Assessment
Patient discomfort will be assessed using a visual analog scale ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort).
Measured: 7 days after intiation CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start9 Jul 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- We will have two groups : an interventional group and a standard of care group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université NAZI BONI
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Ismael Guibla, Université NAZI BONI
- Investigators
- Armand Mekontso-dessap, professor, Study chair, Assistance Publique - Hôpitaux de ParisIsmael Guibla, doctor, Principal investigator, University Hospital Souro Sanou, Burkina FasoIbrahim Alain Traore, professor, Study director, University Hospital Souro Sanou, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912360
- Sponsor's protocol ID
- INSSA 4
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Markou NK, Myrianthefs PM, Baltopoulos GJ. Respiratory failure: an overview. Crit Care Nurs Q. 2004 Oct-Dec;27(4):353-79. doi: 10.1097/00002727-200410000-00006.
PubMed 15537123Stefan MS, Shieh MS, Pekow PS, Rothberg MB, Steingrub JS, Lagu T, Lindenauer PK. Epidemiology and outcomes of acute respiratory failure in the United States, 2001 to 2009: a national survey. J Hosp Med. 2013 Feb;8(2):76-82. doi: 10.1002/jhm.2004. Epub 2013 Jan 18.
PubMed 23335231SRLF Trial Group. Hypoxemia in the ICU: prevalence, treatment, and outcome. Ann Intensive Care. 2018 Aug 13;8(1):82. doi: 10.1186/s13613-018-0424-4.
PubMed 30105416Perkins GD, Ji C, Connolly BA, Couper K, Lall R, Baillie JK, Bradley JM, Dark P, Dave C, De Soyza A, Dennis AV, Devrell A, Fairbairn S, Ghani H, Gorman EA, Green CA, Hart N, Hee SW, Kimbley Z, Madathil S, McGowan N, Messer B, Naisbitt J, Norman C, Parekh D, Parkin EM, Patel J, Regan SE, Ross C, Rostron AJ, Saim M, Simonds AK, Skilton E, Stallard N, Steiner M, Vancheeswaran R, Yeung J, McAuley DF; RECOVERY-RS Collaborators. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):546-558. doi: 10.1001/jama.2022.0028.
PubMed 35072713Templier F, Dolveck F, Baer M, Chauvin M, Fletcher D. [Laboratory testing measurement of FIO2 delivered by Boussignac CPAP system with an input of 100% oxygen]. Ann Fr Anesth Reanim. 2003 Feb;22(2):103-7. doi: 10.1016/s0750-7658(02)00859-6. French.
PubMed 12706763
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of (Continous Positive Airway Pressure) CPAP in the Management of Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06912360
- Acronym / sponsor ID
- INSSA 4
- Conditions
- Acute Respiratory Failure
- Keywords
- CPAP, Acute hypoxemic respiratory failure, Africa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Université NAZI BONIUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 4 Apr 2025 (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 respiratory failure (ARF) is a frequent medical emergency, involving high costs for health organizations and patients who often require intensive care and respiratory assistance. According to an international study, 61% of hypoxemic patients in intensive care receive invasive ventilation [3]. Invasive mechanical ventilation is often unavailable in low-income countries and non-invasive ventilatory supports such as continuous positive airway pressure (CPAP) and high-flow oxygen therapy (HFO) were very useful during the COVID-19 pandemic. They reduced the rate of intubation and ICU admissions. In addition, CPAP can be used without a ventilator, no electricity is required. So, it could be a support of choice in low-income countries.
Used of Boussignac-type CPAP could potentially reduce the recourse to intubation in patients with acute hypoxemic respiratory failure in a context where access to invasive ventilation remains very limited.
Detailed description
- Hypothesis : The use of Boussignac-type CPAP could reduce the need for intubation in patients with acute respiratory failure in a setting where access to invasive ventilation remains very limited.
- Objectives 2.1 Primary Objective The primary objective is to evaluate the effect of CPAP use on the occurrence of intubation criteria at 7 days in patients presenting with ARF in the emergency department. 2.2 Secondary Objectives The secondary objectives are:
- To assess the impact of CPAP use on 28-day mortality in patients with ARF
- To assess the effectiveness of CPAP use on oxygenation in patients with ARF using the SpO2/FiO2 ratio
- To assess the impact of CPAP use on hospital stay
- To assess the safety of CPAP in patients with ARF 2.3 Ancillary Studies The ancillary studies are:
- To assess the contribution of ultrasound in the management of ARF
- To determine the etiologies and prognosis of ARF
- To determine the etiologies and prognosis of patients with ARDS in intensive care
- To assess the cost of ARF management
- Methodology 3.1 Study Setting
The Study will take place in the four adult university hospitals in Burkina Faso. Patient recruitment will take place during the same period in the emergency and intensive care departments. Patient inclusion in each hospital will be under the responsibility of an emergency department physician or an anesthesiologist-intensive care physician.
3.2 Study Type
This will be an open-label, multicenter, national randomized clinical trial. The type of oxygenation device does not allow for a blinded study.
3.3 Study Designs
Within 3 hours of validating the inclusion criteria, patients will be assigned to one of the two groups after signing the consent form.
- In both groups, the oxygen flow will be adjusted to achieve an SpO2 of 92% or higher. SpO2 will be measured either using a monitor with integrated SpO2 measurement or using a portable device such as the Lifebox. The remainder of the patient's care will be administered according to the etiology of the ARF at the physician's discretion and according to recommandations. Any omission from the administration of study treatment will be noted on the collection sheet.
- In the standard group Patients assigned to the standard treatment group will receive oxygen delivered via nasal prongs, simple face masks, or a high-concentration face mask (as needed) until intubation criteria are met, death occurs, or oxygen discontinuation criteria are met (an SpO2 greater than 92% without oxygen and a respiratory rate less than 25 breaths/min).
Patients who meet the intubation criteria will either be intubated if a bed and a ventilator are available in intensive care, or may receive, at the discretion of the physician, CPAP treatment as backup treatment in crossover, if invasive ventilation is not possible.
- In the CPAP group Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to standard oxygen therapy. All study centers will use a Boussignac device connected to an oronasal mask consisting of a transparent mask and a soft inflatable cushion. The CPAP pressure level will be determined by the oxygen flow rate according to the correlation table. CPAP will start at 7.5 cmH2O (i.e., a Boussignac supply of 25 L/min). The pressure level will be decreased to 5 cmH2O (i.e., a Boussignac supply of 20 L/min) or increased to 10 cmH2O (i.e., a Boussignac supply of 30 L/min) depending on clinical response and tolerance. For at least the first 6 to 12 hours, CPAP will be administered continuously, then intermittently (for at least 6 hours/day) depending on patient tolerance. CPAP will be continued until endotracheal intubation criteria are met, death occurs, or treatment is discontinued according to the following criteria: SpO2 greater than 92% and respiratory rate less than 25 breaths/min with 3 L of oxygen or less between CPAP sessions. The criteria for discontinuing oxygen administration will be the same as in the standard group.
Patients who meet the intubation criteria will either be intubated if a bed and ventilator are available in intensive care, or will continue CPAP treatment if invasive ventilation is not possible.
3.4 Stratification
Randomization will be stratified by study center and baseline hypoxemia status. Stratification block randomization will be performed using a centralized, secure electronic system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will have two groups : an interventional group and a standard of care group
| Arm | Type | Receives |
|---|---|---|
| CPAP group | Experimental | Other: CPAPContinuous CPAP (with Boussignac valve) for the first 6-12 hours, then alternating with standard oxygen therapy. CPAP pressure= 7.5 cmH2O (25L/min) then variations of +/- 2.5 cmH20 according to clinical response and tolerance until weaning from oxygen or presence of intubation criteria |
| Standard group | No intervention | –Oxygen therapy as required using, simple face masks or high concentration face masks until there are criteria for intubation, or withdrawal from oxygen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients aged 18 years and older will be included in the study if they meet at least one of the following criteria :
- Acute respiratory distress, defined as dyspnea respiratory rate ≥ 25 cycles/min
- Hypoxemia, defined as the need for more 6 liters of oxygen to maintain an oxygen saturation (SpO2) of ≥ 92%. The fraction of inspired oxygen (FiO2) will be estimated using the 3% rule.
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women
- Persons deprived of their liberty
- Exacerbation of asthma, chronic obstructive pulmonary disease, or another chronic respiratory disease
- Moderate to large amount of unilateral or bilateral undrained pleural effusion
- Contraindication to CPAP: patient refusal, undrained pneumothorax, chest injury, repeated or large vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, or tetraplegia in the initial phase
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 |
|---|---|---|
| CPAPContinuous Positive Airway Pressure (CPAP) with Boussignac valve | Other | CPAP group |
Primary outcome
Proportion of patients with intubation criteria within 7 days
Time frame: 7 days after randomization
The proportion of patients requiring endotracheal intubation within 7 days after randomization. Intubation will be defined as the insertion of an endotracheal tube for invasive invasive mechanical ventilation
3 secondary outcomes
All cause mortality at 28 days
Time frame: 28 days after randomization
Organ failure-free days at 7 days
Time frame: 7 days after randomization
CPAP tolerance Assessment
Time frame: 7 days after intiation CPAP
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 28 Jul 2025.
- Results publication: PubMed 15537123Markou NK, Myrianthefs PM, Baltopoulos GJ. Respiratory failure: an overview. Crit Care Nurs Q. 2004 Oct-Dec;27(4):353-79. doi: 10.1097/00002727-200410000-00006.
- Results publication: PubMed 23335231Stefan MS, Shieh MS, Pekow PS, Rothberg MB, Steingrub JS, Lagu T, Lindenauer PK. Epidemiology and outcomes of acute respiratory failure in the United States, 2001 to 2009: a national survey. J Hosp Med. 2013 Feb;8(2):76-82. doi: 10.1002/jhm.2004. Epub 2013 Jan 18.
- Results publication: PubMed 30105416SRLF Trial Group. Hypoxemia in the ICU: prevalence, treatment, and outcome. Ann Intensive Care. 2018 Aug 13;8(1):82. doi: 10.1186/s13613-018-0424-4.
- Results publication: PubMed 35072713Perkins GD, Ji C, Connolly BA, Couper K, Lall R, Baillie JK, Bradley JM, Dark P, Dave C, De Soyza A, Dennis AV, Devrell A, Fairbairn S, Ghani H, Gorman EA, Green CA, Hart N, Hee SW, Kimbley Z, Madathil S, McGowan N, Messer B, Naisbitt J, Norman C, Parekh D, Parkin EM, Patel J, Regan SE, Ross C, Rostron AJ, Saim M, Simonds AK, Skilton E, Stallard N, Steiner M, Vancheeswaran R, Yeung J, McAuley DF; RECOVERY-RS Collaborators. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):546-558. doi: 10.1001/jama.2022.0028.
- Results publication: PubMed 12706763Templier F, Dolveck F, Baer M, Chauvin M, Fletcher D. [Laboratory testing measurement of FIO2 delivered by Boussignac CPAP system with an input of 100% oxygen]. Ann Fr Anesth Reanim. 2003 Feb;22(2):103-7. doi: 10.1016/s0750-7658(02)00859-6. French.
- 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 Mekontso-dessap, professor study chair
Assistance Publique - Hôpitaux de Paris
Ismael Guibla, doctor principal investigator
University Hospital Souro Sanou, Burkina Faso
Ibrahim Alain Traore, professor study director
University Hospital Souro Sanou, Burkina Faso
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Acute Respiratory Failure, run by Université NAZI BONI at 4 sites in Burkina Faso.
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 10 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Burkina Faso. 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 Ismael Guibla, doctor (+22676135113, ismaelguibla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with intubation criteria within 7 days (time frame: 7 days after randomization). 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 NCT06912360, which also lists 5 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 28 Jul 2025.