Use of Boussignac Continuous Positive Airway Pressure to Reduce Intubation in Adults with Acute Hypoxemic Respiratory Failure in Burkina Faso
Led by Université NAZI BONI · Updated on 2025-07-28
240
Participants Needed
4
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Continuous Positive Airway Pressure CPAP with a Boussignac valve in adults experiencing acute hypoxemic respiratory failure ARF, a serious emergency often requiring intensive care and invasive mechanical ventilation. This trial is focused on settings like Burkina Faso, where access to invasive ventilation is limited, and non-invasive supports such as CPAP could reduce the need for intubation and improve patient outcomes.
Participants will be randomly assigned to one of two groups within three hours of meeting inclusion criteria. The CPAP group will receive continuous CPAP using a Boussignac device for 6 to 12 hours, followed by intermittent use based on tolerance, alongside standard oxygen therapy. The standard group will receive oxygen therapy via nasal prongs or masks until intubation criteria are met, death occurs, or oxygen is no longer needed. Treatment adjustments and intubation decisions depend on clinical status and resource availability.
During the study, participants will be monitored for intubation criteria over 7 days, oxygenation levels, and safety of CPAP use. Other assessments include mortality at 28 days, hospital stay duration, organ failure-free days, and CPAP tolerance. The study will take place in four university hospitals in Burkina Faso, involving emergency and intensive care departments, with follow-up evaluations and data collection conducted accordingly.
CONDITIONS
Brief Title
Continous Positive Airway Pressure (CPAP) Support for Acute Hypoxemic Respiratory Failure in Burkina Faso
Research Team
I
Ismael Guibla, doctor
I
Ibrahim Alain Traore, professor
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Acute respiratory distress with a respiratory rate of 25 breaths per minute or more
Need for more than 6 liters of oxygen to maintain blood oxygen saturation of 92% or higher
You will not qualify if you...
Pregnant or breastfeeding women
Persons deprived of their liberty
Exacerbation of asthma, chronic obstructive pulmonary disease, or other chronic respiratory disease
Moderate to large undrained pleural effusion
Contraindications to CPAP including patient refusal, undrained pneumothorax, chest injury, repeated or large vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, or early tetraplegia
Cardiac arrest, severe arrhythmias, or shock requiring vasopressors
Altered consciousness with Glasgow Coma Scale score less than 13, repeated seizures, or status epilepticus
Medical decision to limit treatment such as no intubation or no ICU admission
Refusal to participate or participation in another interventional respiratory distress study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 7 days or until intubation criteria are met
Participants receive either continuous CPAP support with a Boussignac device for the first 6 to 12 hours followed by intermittent use, or standard oxygen therapy using face masks. Treatment continues until intubation criteria are met, death occurs, or oxygen is discontinued based on clinical parameters.
Daily monitoring visits during treatment
Follow-up
Duration - Up to 28 days after treatment initiation
Participants are monitored for outcomes including survival and organ function for up to 28 days after treatment starts.
Follow-up assessments as needed up to 28 days
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.