CPAP support for acute low-oxygen respiratory failure in Burkina Faso
Use of (Continous Positive Airway Pressure) CPAP in the Management of Acute Hypoxemic Respiratory Failure
This program will try CPAP (a simple non‑electric breathing support) to see if it reduces the need for intubation in adults with acute low‑oxygen respiratory failure in Burkina Faso.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université NAZI BONI Academic / other |
| Locations | 4 sites (Bobo-Dioulasso, Houet and 3 other locations) |
| Trial ID | NCT06912360 on ClinicalTrials.gov |
What this trial studies
Adults presenting with acute hypoxemic respiratory failure in the emergency departments of four university hospitals in Burkina Faso will receive Boussignac‑type CPAP as a non‑invasive respiratory support. The primary outcome is whether CPAP reduces the occurrence of intubation criteria within seven days. Secondary outcomes include 28‑day mortality, oxygenation measured by SpO2/FiO2, hospital length of stay, and safety events. Ancillary analyses will examine the role of ultrasound, determine etiologies and prognosis of ARF and ARDS, and estimate the cost of care.
Who should consider this trial
Good fit: Adults aged 18 or older with acute respiratory distress (respiratory rate ≥25) or needing more than 6 L/min of oxygen to maintain SpO2 ≥92% and no contraindications to CPAP are the intended participants.
Not a fit: Patients with COPD or asthma exacerbations, moderate to large undrained pleural effusion, contraindications to CPAP, pregnant or breastfeeding people, or those deprived of liberty are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, CPAP could lower the need for invasive ventilation and reduce deaths and ICU admissions where mechanical ventilators are scarce.
How similar studies have performed: Non‑invasive supports such as CPAP and high‑flow oxygen reduced intubation rates during the COVID‑19 pandemic, but evidence specifically for low‑resource Boussignac CPAP deployment is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 * 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.
Where this trial is running
Bobo-Dioulasso, Houet and 3 other locations
- Centre Hospitalier Universitaire Souro Sanou — Bobo-Dioulasso, Houet, Burkina Faso (Recruiting)
- CHU Yalgado Ouedraogo — Ouagadougou, Kadiogo, Burkina Faso (Not_yet_recruiting)
- CHU Tengandogo — Ouagadougou, Kadiogo, Burkina Faso (Not_yet_recruiting)
- CHU Bogodogo — Ouagadougou, Kadiogo, Burkina Faso (Not_yet_recruiting)
Study contacts
- Principal investigator: Ismael Guibla, doctor — University Hospital Souro Sanou, Burkina Faso
- Study coordinator: Ismael Guibla, doctor
- Email: ismaelguibla@gmail.com
- Phone: +22676135113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.